siemens jul 0 92014 · 2014-08-08 · siemens jul 0 92014 510(k) summary introduction: according to...

SIEMENS JUL 0 92014510(k) Summary

Introduction: According to the requirements of 21 CER 807.92, the following information provides

sufficient details to understand the basis for determination of substantial equivalence.

The assigned 510(k) Number: k141444

1. SubmitterMailing Address: Siemens Healthcare Diagnostics Inc.

52 10 Pacific Concourse DriveLos Angeles, CA 90045

Contact Person: Donna VelasquezRegulatory Technical Specialist

Phone Number: (31 0)-645-8200 x7403Fax Number: (310)-645-9999E-mail Address: donna.velasquez~siemens.comDate Prepared: May 30, 2014

2. Device NameProprietary Name: IMMULITE® 2000 Cortisol Calibration Verification MaterialMeasurand: Quality Control materials for IMMULITE® 2000 Cortisol assayType of Test: Calibration Verification Material (CVM) for IMMULITE® 2000

Cortisol assayRegulation Section: 21 CER 862.1660, Quality Control MaterialClassification: Class I ReservedProducts Code: JJX - Single (Specified) Analyte Controls (Assayed and

Unassayed)Panel: Clinical Chemistry (75)

3. Predicate Device Name IMMULITE®R 2000 Total T3 Calibration Verification Material(CVM)

Predicate 510(k) No: K133 124

4. Device Description: The IMMULITE® 2000 Cortisol Calibration Verification Material(CVM) contains one set of four vials each 3mL. CVM1 containshuman serum with preservatives and CVM2, CVM3, and CVM4contain various levels of cortisol in human serum withpreservatives.

See Indications for Use Statement below5. Intended Use: The IMMULITE® Cortisol Calibration Verification Material

Indication for Use: (CVM) is for in vitro diagnostic use in the verification ofcalibration of the IMMULITE Cortisol assay on the IMMULITE2000 systems

Special Conditions forUse Statement(s): For prescription use onlySpecial InstrumentRequirements: IMMULITEO 2000 Systems

Pages 1 of 12

SIEMENS6. Technological Characteristics

and Substantial Equivalence A comparison of the device features, intended use, and otherComparison with Predicate: information demonstrates that the IMMULITE® 2000 Cortisol

Calibration Verification Material (CVM) is substantially equivalentto the predicate device as summarized in Table 1.

Table 1: Substantial Equivalence Comparison

________SIMILARITIES

Candidate Device Predicate DeviceIMMULITE 2000 Cortisol CVM[ IMMULITE 2000 Total T3 CVM

Th IMUIT9Cortisol Calibration The IMMULITE® Total T3

Inedd Verification Material (CVM) is for in CairtoVefctonMeilInteded vitro diagnostic use in the verification of (CVM) is for in vitro diagnostic use inuse cairto fteIM LT otsl the verification of calibration of the

aliaion the IMULITE Corsytis. IMMULITE Total T3 assay on theassa onthe MMUITE 000systms.IMMULITE 2000 systems

Storage -20 0C SameForm Liquid Same

Stability Stable unopened until the Sameexpiration date

Levels 4 SameMatrix Human Serum with preservatives Same

Use Single Use Only Same

________DIFFERENCES

Candidate Device Predicate DeviceIMMULITE 2000 Cortisol CVM IMMULITE 2000 Total T4 CVM

Analyte Cortisol Total T3

7. Non-Clinical Performance TestinsPerformance testing has been carried out to demonstrate that this device meets the performancespecifications for its intend use. The following tests were performed on the candidate device.

Stability Summary:IThe stability study was conducted to validate real-time shelf life and open component (in-use or openvial) claim for the IMMULITE 2000 Cortisol Calibration Verification Material (CVM) to ensure thatit maintains optimal product performance on IMMULITE 2000 platforms throughout the establishedshelf life of the CVM. The Calibration Verification Materials are stable up to 14 months when storedat -200 C prior to opening and stable for 8 hours at ambient or room temperature (15-25 0 C) afteropening.

Pages 2 of 12

SIEMENS

Stability Protocol SummaryThe CVM study protocols are run as part of the calibrator stability testing. The stabilitycalibrators/C VMs are run in duplicate (as a minimum) at the time points shown in Table 2, and thedose value is determined from the reference calibrator curve.

Table 2: Stability Protocol SummaryCVM Level Time-Points

___________ __ _____________(Days) _ _ _ _ _ _ _ _

LCOCVM1 1 182 365 425LCOCVM2 1 182 365 425LCOCVM3 1 182 365 425LCOCVM4 1 182 365 425

For Open Component testing, the results were determined from a 2-point adjustment. UsingIMMULITE 2000 Cortisol (L2KCO) kit lot 362, lot 090 CVMs were tested at 2-hourly intervals forup to 9 hours at ambient or room temperature (1 5-250 C) conditions.

Stability Acceptance Criteria SumnmaryThe Acceptance Criteria for the Cortisol Calibration Verification Material (CVM) are in 2 parts.Part I consists of guideline acceptance criteria which require dose value of stabilitycalibrators/CVM to fall between +20% of assigned dose for CVM level 2, +15% of assigned dosefor level 3 and +19% of assigned dose for level 4. Padt 2 review limits criteria which require dosevalue of the controls to be within 2 Standard Deviations (SD) of the control target value whengenerated from the stability calibrator curve. If the result is not within acceptable dose range of +20%for level 2, +15% of assigned dose for level 3 and within +19% of assigned dose for level 4, thenadditional data review is conducted using part 2 criteria.

Traceabilit:The IMMULITE Cortisol CVMs are traceable to an internal material which has been gravimetricallyprepared. The CVMs are manufactured using qualified materials and measurement procedures.

Value Assignment:The IMMULITE Cortisol CVMs are 4 level materials which are a subset of 8 level Cortisolcalibrators. Calibrators are not commercialized but are used internally during manufacture and releasetesting of Cortisol reagents and two point adjustors. The IMMULITE calibrators and thereforeCVMs are value assigned using assigned reference calibrators. The CVMs are manufactured usingqualified materials and measurement procedures. The CVMs dose values are generated using curvegenerated by assigned reference calibrators. The CVM values are calculated based on the recoveredvalues for each run on each instrument independently. CVM values are then averaged across allsystems. Quality control is performed by calculating the recovery of patient samples, spiked patientsamples and controls using the assigned CVM values. Six levels of commercially available controlsand 25 patient serum samples, 3 spiked normal serum samples and 5 normal serum samples were usedto validate calibrator/CVM value assignments.

Pages 3 of 12

SIEMENSExpected Values/Target Values/Reference Range:Each CVM level was tested for a total of 27 replicates; 9 runs and 3 replicates per run, Y differentreagent kit lots and 8 IMMULITE 2000 systems. The Guideline Range (95% confidence interval) foreach CVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). Thetarget values are provided in the IMMULITE® 2000 CVM Calibration verification Material lot-specific value card. The expected assay range is I to 50 g/dL. The target values in Table 3 can beconsidered as guidelines.

Table 3: Analyte Target Range Values

Analyte target CVM, Level *Target' Standard Gluideline +2SDIlevels Mean Deviation Range

g/dL) (SD):LCOCVM1 0.00 - 0. 1.0LCOCVM2 4.54 0.455 3. 5.45LCOCVM3 18.7 1.4 15 21.5LCOCVM4 54.5 5.2 44 64.9

Assay Range 1Ito 50 g/dL*Note: when CVMs are run by the customer, an actual value below and above the assay range will result whenthe customer programs the GyMs as calibration verifiers in the instrument software. If programmed as a patientor control, then the software will give values as < or > the assay lower and upper range.

Each laboratory should establish their limits for acceptability based on methodology, clinicalsignificance and medical decision levels of the test analyte. The representative, total precisiontabulated in the respective assay instructions for use may be considered as one factor whenestablishing local, acceptable ranges. The values provided above may be considered as guidelines.Value assignment is lot specific.

Standard/Guidance Documents Referenced:CEN 13640 Stability Testing of In Vitro Diagnostic ReagentsGuidance for Industry - Abbreviated 5 10(k) Submissions for In Vitro Diagnostic CalibratorsGuidance for Industry and FDA Staff - Assayed and Unassayed Quality Control Material

Proposed Labeling:The labeling is sufficient and it satisfies the requirements of 2l CFR Part 809. 10

8. Conclusion:The IMMULITE® 2000 Cortisol Calibration Verification Material is substantially equivalent to thepredicate device intended for similar use. The substantial equivalence of the device is supported by thenon-clinical testing and was found to be comparable and supports the claims of substantialequivalence, product safety and effectiveness. Based on the testing completed and the comparisonswith predicate device, the IMMULITE®9 2000 Cortisol Calibration Verification Material does not raiseany new questions on safety and effectiveness and the results support a determination of substantialequivalence.

Pages 4 of 12

SIEMENS510(k) Summary

Introduction: According to the requirements of 21 CER 807.92, the following information providessufficient details to understand the basis for determination of substantial equivalence.



5210 Pacific Concourse DriveLos Angeles, CA 90045

Contact Person: Donna VelasquezRegul atory Technical Specialist

Phone Number: (3 10) 645-8200 x7403Fax Number: (310) 645-9999E-mail Address: donna.velasquez~siemens.comDate .Prepared: May 30, 2014

2. Device NameProprietary Name: IMMULITE® 2000 Folic Acid Calibration Verification MaterialMeasurand: Quality Control materials for IMMULITE® 2000 Folic Acid assayType of Test: Calibration Verification Material (CVM) for IMMULITE® 2000

Folic Acid assayRegulation Section: 21 CFR 862.1660, Quality Control MaterialClassification: Class I ReservedProducts Code: JJN - Single (Specified) Analyte Controls (Assayed and

Unassayed)Panel: Clinical Chemistry (75)

3. Predicate Device Name IMMULITE 2000 DHEA-S04 Calibration Verification Material(CVM)

Predicate 510(k) No: K140258

4. Device Description: The IMMULITEO 2000 Folic Acid Calibration VerificationMaterial (CVM) contains one set of four vials, 3mL (CVM I) each,when reconstituted. CVMI contains a lyophilized human albuminbased matrix with preservatives. CVM2, CVM3, and CVM4contain various levels of lyophilized folic acid in human albuminbased matrix with preservatives.

See Indications for Use Statement below5. Intended Use: The IMMULITE® Folic Acid Calibration Verification Material

Indication for Use: (CVM) is for in vitro diagnostic use in the verification ofcalibration of the IMMULITE Folic Acid assay on theIMMULITE 2000 systems

Special Conditions for For prescription use onlyUse Statement(s):Special Instrument IMMULITE® 2000 SystemsRequirements:

Pages 5Sof 12

SIEMENS6. Technological Characteristics, A comparison of the device features, intended use, and other

and Substantial Equivalence information demonstrates that the IMMULITE9 2000 Folic AcidComparison with Predicate: Calibration Verification Material (CVM) is substantially equivalent

to the predicate device as summarized in Table 1.

Table 1: Substantial Equivalence ComparisonSIMILARITIES

Candidate Device Predicate DeviceIMMULITE 2000 DHEA-S04

IMMULITE 2000 Folic Acid CVM CVM

The IMMULITE® Folic Acid The IMMULITE® DHEA-S04Calibration Verification Material (CVM) Calibration Verification Material

intended is for, in vitro diagnostic use in the (CVM) is for in vitro diagnostic useUse verification of calibration of the in the verification of calibration of

IMMULITE Folic Acid assay on the the IMMULITE DHEA-S04 assayIMMULITE 2000 systems on the IMMULITE 2000 systems

Form Lyophilized SameLevels 4 SameStability Stable unopened until the expiration date Same

Storage -20 0 C Same


________DIFFERENCES

Candidate Device Predicate Device

IMMULITE 2000 Folic Acid CVM CVMIT 00 HE-0

Analyte Folic Acid DHEA-S04Matrix Human Albumin with preservatives Human Serum with Preservatives

7. Non-Clinical Performance TestingPerformance testing has been carried out to demonstrate that this device meets the performancespecifications for its intend use. The following tests were performed on the candidate device.

Stability Summary:The stability study was conducted to validate real-time shelf life and open component (in-use or openvial) claim for the IMMULITE 2000 Folic Acid Calibration Verification Material (CVM) to ensurethat it maintains optimal product performance on IMMULITE 2000 platforms throughout theestablished shelf life of the CVM. The Calibration Verification Materials are stable up to 3.5 yearswhen stored at -20'C prior to opening, and for 8 hours at ambient or room temperature (15-25 0 C)after reconstitution.

Stability Protocol Summary:The CVM study protocols are run as part of the calibrator stability testing. The stability CVMsand reference CVMs are run in duplicate (as a minimum) at the time points shown in Table 2and the dose value determined from the reference calibrator curve.

Pages 6 of 12

SIEMENSTable 2: Stability Protocol summary

CVM Level Time-Points

LEOCVMI19110528LFOCVM2- 9110528LFOCVM3 9110528LFOCVM419110528

For Open Component testing, the results were determined from a 2-point adjustment. UsingJMMULITE 2000 Folic Acid (L2KFO) kit lot 446, lot 090B Folic Acid CVMs were tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (1 5-25 0 C) conditions.

Stability Acceptance Criteria Summary:The Acceptance Criteria for the IMMULITE Folic Acid Calibration Verification Material (CVM) arein 2 parts. Part I consists of guideline acceptance criteria which require dose value of stability CVMsto fall between +15% of the assigned dose for CVM level 2, within ±10% of the assigned dose forlevel 3 and within ±12% of assigned dose for CVM level 4. Part 2 review limits criteria which requiredose value of the controls to be within 2 Standard Deviations (SD) of the control target value whengenerated from the stability calibrator curve. If the result is not within acceptable dose range of +1 5%of the assigned dose for CVM level 2, within ±10% of the assigned dose for level 3 and within ±12%of assigned dose for CVM level 4 then additional data review is conducted using part 2 criteria.

Traceabilit:The IMMULITE Folic Acid CVMs are traceable to an internal material which has beengravimetrically prepared. The CVMs are manufactured using qualified materials and measurementprocedures.

Value Assignment:The IMMULITE Folic Acid CVMs are 4 level materials which are a subset of 8 level Folic Acidcalibrators. Calibrators are not commercialized but are used internally during manufacture and releasetesting of Folic Acid reagents and two point adjustors. The IMMULITE calibrators and thereforeCVMs are value assigned using assigned reference calibrators. The CVMs dose values are generatedusing curve generated by assigned reference calibrators. The CVM values are calculate d based on therecovered values for each run on each instrument independently. The CVM values are then averagedacross all systems. Quality control is performed by calculating the recovery of patient samples andcontrols using the assigned CVM values. The controls must fall within their target ranges. Six levelsof commercially available controls and 14 patient serum samples, 12 fasting samples were used tovalidate calibrator/CVM value assignments.

Expected Values/Target Values/Reference Range:The CVMs are manufactured using qualified materials and measurement procedures. The Folic AcidCVMs were tested on 27 replicates in total comprised of 9 runs and 3 replicates per run on 6IMMULITE 2000 systems and 3 different reagent kit lots. The CVMs dose values are generated usingcurve generated by assigned reference calibrators. The CVM values are calculated based on therecovered values for each run on each instrument independently. The CVM values are then averagedacross all systems. Quality control is performed by calculating the recovery of patient samples andcontrols using the assigned CVM values. The Guideline Range (95% confidence interval) for eachCVM level was established based on the Target Mean and ± 2 Standard Deviation (SD). The expectedassay range is I to 24 ng/mL. The target values in Table 3 can be considered as guidelines.

Pages 7 of 12

SIEMENSTable 3: Analyte Target Range Levels _____

Analyte target CVM Level *Target Standard Guideline ±2S11 Rangelevels Mean Deviation ing/mL)

_______________ (ng/mL) (SD) _______

_LFOCVM1 0.00 - 0.00 1.0LFOCVM2 3.11 0.28 2.55 3.67LFOCVM3 12.4 0.75 10.9 13.9LFOCVM4 26.3 1.6 23.1 29:5

Assay Range I to 24 ng/mL*Note: when CVMs are run by the customer, an actual value below and above the assay range will result whenthe customer programs the CVMs as calibration verifiers in the instrument software. If programmed as a patientor control, then the software will give values as < or > the assay lower and upper range.



Proposed Labeling:The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809. 10

8. Conclusion:The IMMVULITEO 2000 Folic Acid Calibration Verification Material is substantially equivalent to thepredicate device intended for similar use. The substantial equivalence of the device is supported by thenon-clinical testing and was found to be comparable and supports the claims of substantialequivalence, product safety and effectiveness. Based on the testing completed and the comparisonswith predicate device, the IMMULITE® 2000 Folic Acid Calibration Verification Material does notraise any new questio~ns on safety and effectiveness and the results support a determination ofsubstantial equivalence.

Pajes 8 of 12

SIEMENS510(k) Summary

Introduction: According to the requirements of 21 CFR 807.92, the following information providessufficient details to understand the basis for determination of substantial equivalence.



5210 Pacific Concourse DriveLos Angeles, CA 90045

Contact Person: Donna VelasquezRegulatory Technical Specialist

Phone Number: (31 0)-645-8200 x7403Fax Number: (310)-645-9999E-mail Address: donna.velasquez~siemens.comDate Prepared: May 30, 2014

2. Device NameProprietary Name: IMMULITE® 2000 Vitamin Bl12 Calibration Verification MaterialMeasurand: Quality Control materials for IMMULITE 2000 Vitamin B12Type of Test: Calibration Verification Material (CVM) for IMMULITE® 2000

Vitamin B12 assayRegulation Section: 21 CER 862.1660, Quality Control MaterialClassification: Class I ReservedProducts Code: JJN - Single (Specified) Analyte Controls (Assayed and Unassayed)Panel: Clinical ' Chemistry (75)

3. Predicate Device Name IMMULITE® 2000 DHEA-S04 Calibration Verification MaterialPredicate 510(k) No: K140258

4. Device Description: IMMULITE®V 2000 Vitamin B12 Calibration Verification Material(CVM) contains one set of four vials, 3 mL each, when reconstituted.CVM I contains a lyophilized human albumin-based matrix withpreservatives. CVM2, CVM3, and CVM4 contain various levels oflyophilized Vitamin 812 in human albumin-based matrix withpreservatives.

5. Intended Use: See Indications for Use Statement belowIndication for Use: The IMMULITE® Vitamin B312 Calibration Verification Material

(CVM) is for in vitro diagnostic use in the verification of theIMMULITE Vitamin B1 2 assay on the IMMULITE 2000 systems

Special Conditions forUse Statement(s): For prescription use onlySpecial InstrumentRequirements: IMMULITE® 2000 Systems

Pages 9Sof 12

SIEMENS6. Technologzical Characteristics A comparison of the device features, intended use, and other

and Substantial Equivalence information demonstrates that the IMMfULITE®@ 2000 Vitamin B12Comparison with Predicate: Calibration Verification Material (CVM) is substantially equivalent

to the predicate device, as summarized in Table 1.

Table 1: Substantial Equivalence CornparisonSIMILARITIES

Candidate Device Predicate DeviceIMMULITE 2000 Vitamin 1112 CVM IMMULITE 2000 DHEA-S04 CVM

The IMMULITE® Vitamin B12 The IMMULITE®) DHEA-S04Calibration Verification Material Calibration Verification Material

Intended (CVM) is for in vitro diagnostic use in (CVM) is for in vitro diagnostic use inUse the verification of calibration of the the verification of calibration of the

IMMULITE Vitamin B112 assay on the IMMU LITE DHEA-S04 assay on the________IMMULITE 2000 systems. IMMULITE 2000 systems

Form Lyophilized SameStability Stable unopened until the Same

expiration dateStorage -20 0C SameLevels 4 Same


________DIFFERENCES

Candidate Device Predicate Device______IMMULITE 2000 Vitamin 1112 CVM IMMULITE 2000 DHEA-504 CVM

Analyte Vitamin B 12 DHEA-S04Matrix Human Albumin with preservatives Human Serum with preservatives

7. Non-Clinical Performance TestingPerformance testing has been carried out to demonstrate that this device meets the performancespecifications for its intend use. The following tests were performed on the candidate device.

Stability Summary:The stability study was conducted to validate real-time shelf life and open component (in-use dr openvial) claim for the IMMULITE 2000 Vitamin B12 CVM to ensure that it maintains optimal productperformance on IMMULITE 2000 platforms throughout the established shelf life of the CVM. TheCalibration Verification Materials are stable up to 69 months when stored at -20 0C prior to openingand'stable for 8 hours at room (ambient) temperature (I 5-25 0 C) after reconstitution.

Stability Protocol Summary:The CYM study protocols are run as part of the calibrator stability testing. As summarized in Table 2,the testing was run in duplicate (at the minimum) and contains time-points at which the testing wasperformed.

Pages 10 of 12

SIEMENSTable 2: Stability Protocol Summary

CVM Level Time-Points___________(Months)

LVBCVM1 0 67 168 69LVBCVM2 0 67 68 69LVBCVM3 0 67 68 69LVBCVM4 0 67 68 69

For Open Component testing, the results were determined from a 2-point adjustment. UsingIMMULITE 2000 Vitamin B12 (L2KVB) kit lot 467, lot 108 Vitamin B12 CVMs were tested at 2-hourly intervals for up to 9 hours at ambient or room temperature (I15-25 0 C) conditions.

Stability Acceptance Criteria Summary:The Acceptance Criteria for the IMMULITE Vitamin B12 Calibration Verification Material (CVM)are in 2 parts. Part 1 consists of guideline acceptance criteria which require dose value of stabilitycalibrator/CVM to fall between +10% of assigned dose for CVM level 2 and level 3 and within +21%of assigned dose for CVM level 4. Part 2 review limits criteria which require dose value of thecontrols to be within 2SD of the control target value when generated from the stability calibratorcurve. If the result is not within acceptable dose range of ±10% for level 2 and level 3 and ±21% forlevel 4, then additional data review is conducted using part 2 criteria.

Traceability:The IMMULITE Vitamin B12 CVMs are traceable to an internal standard. The CVMs aremanufactured using qualified materials and measurement procedures.

Value Assignment:The IMMULITE®V 2000 Vitamin B12 CVMs are 4 level materials which are a subset of 8 levelVitamin B12 calibrators. Calibrators are not commercialized but are used internally duringmanufacture and release testing of Vitamin B12 reagents and two point adjustors. The IMMULITEcalibrators and therefore CVMs are value assigned using assigned reference calibrators. The CVMsdose values are generated using curve generated by assigned reference calibrators. The CVM valuesare calculated based on the recovered values for each run on each instrument independently. CVMvalues are then averaged across all systems. Quality control is performed by calculating the recoveryof patient samples and controls using the assigned CVM values. Eight levels of commerciallyavailable controls and 21 patient serum samples were used to validate CVM value assignments.

Pages 11 of 12

SIEMENSExpected Values/Target Values/Reference Range:The Vitamin B12 CVMs were tested on 24 replicates in total comprised of 12 runs and 2 replicatesper run, 3 IMMULITE 2000 and 5 IMMULITE/IMMU LITE 1000 systems and 4 different reagent kitlots. The CVMs dose values are generated using curve generated by assigned reference calibrators.The CVM values are calculated based on the recovered values for each run on each instrumentindependently. CVM values are then averaged across all systems. Quality control is performed bycalculating the recovery of patient samples and controls using the assigned CVM values. TheGuideline Range (95% confidence interval) for each CVM level was established based on the TargetMean and ± 2 Standard Deviation (SD). The expected assay range is 150 to 1000 pg/mL. The targetvalues in Table 3 can be considered as guidelines.

Table 3: Analyte Target Range Levels

Analyte target Level *'Ta Irget Standard - 'Guideline ±ZSD Rangelevels Mean, Deviation -1i(ng/mL)

(ng/mL) (SD)LVBCVM1 0.00 - 0.00 150LVBCVM2 234 23.5 187 281LVBCVM3 579 34.5 510 648

_______LVBCVM4 1144 194.5 755 1533Assay Range 15 0 to 1000 pg/mL

*Note: when CVMs are run by the customer, an actual value below and above the assay range will result whenthe customer programs the GyMs as calibration verifiers in the instrument software. If programmed as a patientor control, then the software will give values as < or > the assay lower and upperrange.



Proposed Labeling:IThe labeling is sufficient and it satisfies the requirements of 21 CFR Part 809. 10

9. Conclusion:

The IMIMULITEV 2000 Vitamin B 12 Calibration Verification Material is substantially equivalent tothe predicate device intended for similar use. The substantial equivalence of the device is supported bythe non-clinical testing and was found to be comparable and supports the claims of substantialequivalence, product safety and effectiveness. Based on the testing completed and the comparisonswith predicate device, the IMMULITE®) 2000 Vitamin B 12 Calibration Verification Material does notraise any new questions on safety and effectiveness and the results support a determination ofsubstantial equivalence.

Pages 12 of 12

DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

S4 Food and Drug Adminisnraion10903 New Hampshire AvenueDocument Control Center - W066-6609Silve Spring. MD 2M93-M02

July 9, 2024

SIEMENS HEALTHCARE DIAGNOSTICS, INC.C/O DONNA VELASQUEZREGULATORY TECHNICAL SPECIALIST5210 PACIFIC CONCURSE DRIVELOS ANGELES CA 90045

Re: kI14l444Trade/Dievice Name: IMMULITE" 2000 Cortisol Calibration Verification Material

IMMULITE" 2000 Folic Acid Calibration Verification MaterialIMMULITE® 2000 Vitamin B 12 Calibration Verification Material

Regulation Number: 21 CFR 862.1660Regulation Name: Quality Control Material (assayed and unassayed)Regulatory Class: 1, ReservedProduct Code: JJXDated: June 3, 2014Received: June 5, 2014

Dear Donna Velasquez:

We have reviewed your Section 51 0(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of' the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA), itmay be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

Ms. Donna Velasquez

device-related adverse events) (21 CUR 803): good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 ofthe Act): 21 CFR 1000-1050.

If you desire spfecific advice for your device on our labeling regulation (21 CFR Part 801 ). pleasecontact the Division of Indlustry and Consumer Education at its toll-free number (800) 638-2041or (301) 796-7 100 or at its Internet addresslltti)://w'vw\.f'ca,.!,,ov/Medical Deviccs/lResotrccsf'or-Yoi/niduiStrv\/dIcf'auLlt.htin. Also, please notethe regulation entitled. "Misbranding by reference to premarket notification" (21 CUR Part807.97). For questions regarding thle reporting of adverse events tinder the MDR regulation (21CUR Part 803), please go to

httm/ww~lca~uv/Nled~al~vics/Slci/Reortarobem/elalt~itmfor the CDRI-Is Officeof Surveillance and Biometrics/Division of Posimarket Surveillance.

You may obtain other general information onl your responsibilities under the Act from theDivision of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301)796-7100 or at its Internet address

Sincerely yours.

Courtney H. Lias -SCourtney 1-. LiasDirectorDivision of Chemistry and Toxicology DevicesOffice of In Vitro Diagtnosticsdnd Radiological HeIalthCenter for Devices and Radiological Health

Enclosure'

510(k) Number (if known)k 14 1414

Device NameIt\ MU LI TE@ 2000 Cortisol Calibiat ion Vei i fiatie;; Matei i!I NI U LiTIA0 2000 F'olic Acid Cal ibiation Veil ficutiun Mater ial

lNILlU~TE~2000 \'itain B312 Calibition \lerification Material

Indications for Use (Describe)Thle !MM4ULITE® Cortisol Calibrationt Verification Mater ial is for in vitro diagnostic use in tlie verification of caiibratioaof the IMMULLITE Cortisol assay onl the IMMULIT17 2000 systems.

The IMMULITE® Folic Acid Calibration Veil lication Material is for in vitro diagnostic use inl tlie velifiention of'calibration of the fvIULITE Folic Acid assay on tile IMMULITE 2000 systems.

1 ie IMMI.Ti®111 Vitamlin B 12 Calibration Ver ification Maerial is lor in vitro diagnostic use in tile verification ofcalibration of tlie IMMULITE Vitamin B 12 assay on; (lie IMMULIIE 2000 systems.

Type of Use (Select one or both, as applicable)

MPrescription Use (Part 21 CFR 801 Subpart D) l Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLYConcurrence of Center for Devices and Radiological IHealth (CORI I) (Signature)

Yung .W.,, Ch~an -SThis section applies only to requirements of thle Paperwork Reduction Act of 1995.

hDO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*The burden time for this collection of information Is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of Information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:

Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRASloff~fdao.liis.gov

"Ar; agency may not conduct or sponsor, and a person Is not requiredi to respond to, a collection ofinform~ation unless it dlisplays a curt ly valid 0MB number"'

FORM FDA 3881 (1114) Page I of I I4IN 4ol l ~