U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 3 . 0 3 Silver Spring, MD 20993 www.fda.gov

December 14, 2018 Sebia, Inc. Karen Anderson Director of Technical & Regulatory 1705 Corporate Drive, Suite 400 Norcross, Georgia 30093 Re: K180762

Trade/Device Name: CAPI 3 HEMOGLOBIN(E) Regulation Number: 21 CFR 864.7415 Regulation Name: Abnormal hemoglobin assay Regulatory Class: Class II Product Code: GKA Dated: March 23, 2018 Received: March 23, 2018

Dear Karen Anderson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

K180762 - Karen Anderson Page

2

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

Leonthena R. Carrington -S

510(k) Summary 1

040 1

510K SUMMARY (Summary of Safety and Effectiveness)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with

the requirements of 21 CFR 807.92.

Submitter Name

Sebia, Inc.

Address

1705 Corporate Drive Suite 400

Norcross, Georgia 30093, USA

Contact

Karen Anderson, Dir of Technical and Regulatory

Phone: 1-800-835-6497, 3704

Fax: 770-446-8511

Email: karen.anderson@sebia-usa.com

Matthew C. Wagner, Ph.D. Scientific

Affairs Specialist

Phone: 1-800-835-6497

Email: matthew.wagner@sebia-usa.com

Date Prepared December 13, 2018

Manufacturing

Sebia

Parc Technologique Léonard de Vinci

Rue Léonard de Vinci,

CP 8010 LISSES, 91008 EVRY Cedex

FRANCE

Phone: (33) 1 69 89 80 80

Fax: (33) 1 69 89 78 78

Product Name

CAPI 3 HEMOGLOBIN(E)

Common Name

Hemoglobin by capillary electrophoresis

Product Regulation No.

21 CFR 864.7415

510(k) Summary 2

040 2

Product Codes , Device

classification and Panel

Classification

GKA, Class II , Hematology (81)

Establishment Registration No. 8023024

1. DEVICE DESCRIPTION

The CAPILLARYS 3 instrument uses the principle of capillary electrophoresis in free

solution which is the most common form of capillary electrophoresis. With this technique,

charged molecules are separated by their electrophoretic mobility in an alkaline buffer

with a specific pH. Separation also occurs according to the electrolyte pH and

electroosmotic flow.

The CAPILLARYS 3 instrument has silica capillaries functioning in parallel allowing 12

simultaneous analyses for hemoglobin quantification in a whole blood sample. A sample

dilution with hemolysing solution is prepared and injected by aspiration at the anodic end

of the capillary. A high voltage protein separation is then performed and direct detection

of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the

absorbance wave length specific to hemoglobins. Before each run, the capillaries are

washed with a wash solution and prepared for the next analysis with buffer.

Direct detection provides accurate relative quantification of individual hemoglobin

fraction, and the resulting electrophoregrams are also evaluated visually for pattern

abnormalities. In addition, the high resolution of this procedure should allow the

identification of hemoglobin variants, in particular, to differentiate hemoglobins S from D,

and E from C. The hemoglobin A2 quantification can also be performed when hemoglobin

E is present. A2 hemoglobin quantification may be used with other clinical and laboratory

findings for ß thalassemia detection.

By using alkaline pH buffer, normal and abnormal (or variant) hemoglobins are detected

in the following order, from cathode to anode: δA’2 (A2 variant), C, A2, E, S, D, F, and

A.

The carbonic anhydrase is not visualized on the hemoglobin electrophoretic patterns by

capillary electrophoresis, this permits to identify hemoglobin A2 variants in this migration

zone.

NOTE : the name "CAPILLARYS 3" is used for the SEBIA CAPILLARYS 3 TERA automated

instrument.

The hemoglobins are reported in % units along with an electrophoresis scan.

510(k) Summary 3

040 3

Reagents:

CAPI 3 HEMOGLOBIN(E) KIT

ITEMS PN 2507

Buffer (ready to use) 2 vials, 700 mL each

Hemolysing solution (ready to use) 1 vial, 700 mL

Filters 4 filters

Additional reagents and accessories not included in the CAPI 3 HEMOGLOBIN(E) KIT

ITEMS PN COMPONENTS

CAPICLEAN CAPILLARYS 3 2060 1 vial, 25 mL

CAPILLARYS 3 WASH SOLUTION 2062 1 vial, 75mL

CAPI 3 REAGENT CUPS 2582 24 X 14 packs of reagent cups

TEST TUBES 9214 200 of 100 mm-tubes

CAPI 3 BINS 2581 5 units

TUBES AND CAPS FOR

CONTROLS

9202

9205

20 units

500 units

CAPILLARYS 3 & MC SWITCH

RACK FOR HEMOGLOBIN(E) 1373 1 unit

CAPILLARYS 3 & MC LOW

VOLUME RACKS 1364 5 units

SEBIA CAPILLARYS 3 1246 1 unit

2. INDICATIONS FOR USE

CAPI 3 HEMOGLOBIN(E) kit:

The CAPI 3 HEMOGLOBIN(E) kit is designed for the separation of the normal

hemoglobins (A, A2 and F) in human venous blood samples, and for the detection of the

major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer

(pH 9.4) with the SEBIA CAPILLARYS 3 TERA instrument.

The CAPILLARYS 3 TERA instrument is an automated analyzer which performs a

complete hemoglobin profile for the quantitative analysis of the normal hemoglobin

fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D.

The assay is performed on the hemolysate of whole blood samples collected in tubes

510(k) Summary 4

040 4

containing K2EDTA or K3EDTA as anticoagulant. The CAPI 3 HEMOGLOBIN(E) is

intended to be used in conjunction with other laboratory and clinical findings.

For In Vitro Diagnostic Use.

3. TECHNOLOGICAL CHARACTERISTICS

The CAPILLARYS 3 instrument in combination with the CAPI3 HEMOGLOBIN(E) kit

uses the principle of capillary electrophoresis in free solution which is the most common

form of capillary electrophoresis. With this technique, charged molecules are separated

by their electrophoretic mobility in an alkaline buffer with a specific pH. Separation also

occurs according to the electrolyte pH and electroosmotic flow.

The CAPILLARYS 3 instrument has silica capillaries functioning in parallel allowing 12

simultaneous analyses for hemoglobin quantification in a whole blood sample. A sample

dilution with hemolysing solution is prepared and injected by aspiration at the anodic end

of the capillary. A high voltage protein separation is then performed and direct detection

of the hemoglobins is made at the cathodic end of the capillary at 415 nm, which is the

absorbance wave length specific to hemoglobins. Before each run, the capillaries are

washed with a wash solution and prepared for the next analysis with buffer.

Direct detection provides accurate relative quantification of individual hemoglobin

fraction, and the resulting electrophoregrams are also evaluated visually for pattern

abnormalities. In addition, the high resolution of this procedure should allow the

identification of hemoglobin variants, in particular, to differentiate hemoglobins S from D,

and E from C. The hemoglobin A2 quantification can also be performed when hemoglobin

E is present. A2 hemoglobin quantification may be used with other clinical and laboratory

findings for ß thalassemia detection.. By using alkaline pH buffer, normal and abnormal

(or variant) hemoglobins are detected in the following order, from cathode to anode: δA’2

(A2 variant), C, A2, E, S, D, F and A. The carbonic anhydrase is not visualized on the

hemoglobin electrophoretic patterns by capillary electrophoresis, this permits to identify

hemoglobin A2 variants in this migration zone.

4. SUBSTANTIAL EQUIVALENCE INFORMATION:

Predicate Device Name Predicate

Device

510(k) number

Product

Code

Regulation

No.

CAPILLARYS HEMOGLOBIN(E) using the CAPILLARYS 2 FLEX-PIERCING instrument,

K112550 GKA 864.7415

510(k) Summary 5

040 5

Similarities between the candidate device (CAPI 3 HEMOGLOBIN(E)) and the predicate device

(CAPILLARYS HEMOGLOBIN(E)), K112550 (Table A).

Similarities

Table A Sebia CAPI 3 HEMOGLOBIN(E)

Candidate Device

Sebia CAPILLARYS HEMOGLOBIN(E)

Predicate Device (K112550)

Intended use

. The CAPI 3 HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human venous blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 3 TERA instrument. The CAPILLARYS 3 TERA instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of whole blood samples collected in tubes containing K2EDTA or K3EDTA as anticoagulant. The CAPI 3 HEMOGLOBIN(E) is intended to be used in conjunction with other laboratory and clinical findings. For In Vitro Diagnostic Use.

The CAPILLARYS HEMOGLOBIN(E) kit is designed for the separation of the normal hemoglobins (A, A2 and F) in human blood samples, and for the detection of the major hemoglobin variants (S, C, E and D), by capillary electrophoresis in alkaline buffer (pH 9.4) with the SEBIA CAPILLARYS 2 FLEX-PIERCING instrument. The CAPILLARYS 2 FLEXPIERCING instrument is an automated analyzer which performs a complete hemoglobin profile for the quantitative analysis of the normal hemoglobin fractions A, A2 and F and for the detection of major hemoglobin variants S, C, E and D. The assay is performed on the hemolysate of whole blood samples collected in tubes containing K2EDTA or K3EDTA as anticoagulant. For In Vitro Diagnostic Use.

Specimen Type Venous Human Whole Blood Same

Technology CAPILLARYS ELECTROPHORESIS Same

DETECTION Absorbance Wavelength

415 nm Same

Software PHORESIS Same

Barcode Identification of

Same On-board

Same

Controls for

migration Sebia Normal A2 Control ( sold separately)

Same

Buffer and

Composition CAPILLARYS HEMOGLOBIN(E)

Same

Use of Buffer

Solution On-Board

Same

510(k) Summary 6

040 6

Wash Solution

and Composition Same

Same

Use of the Wash

Solution On-Board

Same

Hemolysing Solution and Composition

On-Board Same

Use of Hemolysing

Solution On-Board

Same

Reference Range

Hb A 96.7-97.8%

HbF ≤ 0.5 % Hb A2 2.2-3.2 %

Same

Hb variants library

(on-board) Yes, displayed by the software and indicated

in the package insert) Same

Table B. Differences between the candidate device (CAPI 3 HEMOGLOBIN(E)) and the

predicate device (CAPILLARYS HEMOGLOBIN(E), K112550 in (Table B).

Differences

Table B Sebia CAPI 3 HEMOGLOBIN(E)

Candidate Device Sebia CAPILLARYS HEMOGLOBIN(E)

Predicate Device (K112550)

Number of Separation

units ( Capillaries) 12 8

Bottle for reagents RFID tag

None

Reagent Cups Supplied separate packaging Supplied in the kit

Wash Solution Supplied separate packaging Supplied in the kit

5. Performance Data:

a. Precision / Reproducibility:-

The precision of the CAPI 3 HEMOGLOBIN(E) procedure was evaluated in studies based on the

Clinical and Laboratory Standards Institute (CLSI - USA) EP5-A3 guideline "Evaluation of

Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition".

The means, standard deviations (SD) and coefficients of variation (CV %) were calculated for

percentage (%) of hemoglobin fractions for each sample.

510(k) Summary 7

040 7

7-days reproducibility study with three instruments and one lot of kit

Seven (7) different native blood samples were run using the CAPI 3 HEMOGLOBIN(E) procedure

performed with three CAPILLARYS 3 TERA instruments.

The 7-days reproducibility performed with three CAPILLARYS 3 instrument and one lot of CAPI

3 HEMOGLOBIN(E) kit is summarized in the following tables including within-run, between-run,

between-day, between-instrument and total reproducibility precision estimates (SD and % CV

ranges) for the percentages (%) of each hemoglobin fraction from all samples.

20-days reproducibility study with one instrument and one lot of kit

Five (5) different samples were run using the CAPI 3 HEMOGLOBIN(E) procedure performed

with one CAPILLARYS 3 instrument and one lot on CAPI 3 HEMOGLOBIN(E) kit. Each sample

was analyzed in duplicate on twelve capillaries per run, two runs per day over 20 days yielding a

total of 960 results per sample.

The 20-days reproducibility performed with one CAPILLARYS 3 instrument and one lot of CAPI 3

HEMOGLOBIN(E) kit is summarized in the following tables including within-capillary, between-

capillary, between-run, between-day and total reproducibility precision estimates (SD and % CV

ranges) for the percentages (%) of each hemoglobin fraction from all samples

CAPI 3 HEMOGLOBIN(E) & CAPILLARYS 3 TERA : Reproducibility study on native whole blood samples (2018/10)

Fraction Min Value Max Value SD min SD max CV min CV max SD min SD max CV min CV max SD min SD max CV min CV max

Hb A 56,5 97,5 0,03 0,39 0,0% 0,6% 0,00 0,22 0,0% 0,4% 0,00 0,73 0,0% 1,3%

Hb A2 1,9 4,8 0,03 0,14 1,1% 5,2% 0,00 0,05 0,0% 1,6% 0,00 0,11 0,0% 3,8%

Hb F

Hb S

Hb C

Hb D

Hb E

0,84

Ranges of % tested Within-run Between-run Between-day

34,9 0,15 0,4% 0,08 0,2%

40,1 0,14 0,4% 0,06 0,1%

2,4%

0,28

0,10 0,2%

34,3 0,36 1,1% 0,11 0,3%

38,6 0,15 0,4% 0,11 0,3%

0,8%

0,50 1,3%

1,4%23,5 0,18 0,8% 0,00 0,0% 0,32

Fraction Min Value Max Value SD min SD max CV min CV max SD min SD max CV min CV max

Hb A 56,5 97,5 0,00 0,14 0,0% 0,2% 0,03 0,84 0,0% 1,3%

Hb A2 1,9 4,8 0,00 0,03 0,0% 0,5% 0,03 0,17 1,3% 6,5%

Hb F

Hb S

Hb C

Hb D

Hb E

(*) Total reproducibility includes : within-run, between-run, between-day and between-instrument.

Between-instrument Total reproducibility(*)Ranges of % tested

34,9

40,1 0,24 0,6%

0,00 0,0% 0,86 2,5%

0,16 0,4%

34,3

38,6 0,54 1,4%

0,00 0,0% 0,47 1,4%

0,00 0,0%

0,00 0,0% 0,37 1,6%23,5

CAPI 3 HEMOGLOBIN(E) & CAPILLARYS 3 TERA : 20-days reproducibility study with one instrument and one lot of kit (2018/10)

Fraction Min Value Max Value SD min SD max CV min CV max SD min SD max CV min CV max SD min SD max CV min CV max

Hb A 44,2 97,3 0,04 0,31 0,0% 0,5% 0,01 0,16 0,0% 0,4% 0,00 0,14 0,0% 0,3%

Hb A2 2,6 6,5 0,04 0,09 0,8% 3,1% 0,02 0,12 0,9% 4,4% 0,00 0,06 0,0% 2,4%

Hb F

Hb S

Hb C

Hb D

Hb E

0,048,9 0,08 0,9% 0,07 0,8% 0,4%

0,02 0,1%

0,1% 0,14

17,5 0,06 0,4% 0,08 0,5%

26,8 0,12 0,4% 0,02

0,09

40,6 0,19 0,5% 0,1%0,06 0,2% 0,05

22,6 0,23 1,0% 0,02 0,1%

Ranges of % tested Within-capillary Between-capillary Between-run

0,4%

0,5%

510(k) Summary 8

040 8

b. Linearity

A linearity study was performed per CLSI EP06-A: Evaluation of Quantitative Measuring

Procedures; A Statistical Approach. The results for percentage (%) of hemoglobin fractions

were analyzed using statistical tools recommended by CLSI.

Mixtures of two different blood samples were mixed at different proportions and tested in

triplicate and analyzed using the CAPI 3 HEMOGLOBIN(E) procedure on the CAPILLARYS 3

instrument. The tests were determined to be linear within the entire range studied for each of

the following hemoglobins fractions:

Hb A ( 1.0 -97.3%), HbS (1.1-89.7%), Hb A2 (0.2-9.1%), Hb F (0.5-83.1%), Hb C (0.3-82.0%), Hb

D (1.1-43.5%), Hb E (0.3-86.9%).

c. Limit of Blank (LOB), Limit of Detection (LOD), Limit of Quantitation (LOQ)

Per CLSI guidelines , EP17-A, Protocols for Determination of Limits of Detection and Limits of

Quantitation , studies were conducted using the CAPI 3 HEMOGLOBIN(E) procedure using

the CAPILLARYS 3 for each hemoglobin fraction using five (5) different blood samples. Results

are as follows:

Fraction LOB % LOD % LOQ %

Hb A 0,1 1,0 1,0

Hb A2 0,1 0,2 0,2

Hb F 0,2 0,4 0,5

Hb S 0,1 0,9 1,1

Hb C 0,1 0,3 0,3

Hb D 0,1 0,7 1,1

Hb E 0,1 0,3 0,3

d. Analytical Specificity

Interference studies were conducted following CLSI, EP7-A2, Interference Testing in Clinical

Chemistry. Three (3) blood samples (one blood sample with normal Hb A2 level, one blood

sample with increased Hb A2 level and one blood sample with Hb S). Each sample was

analyzed 3 times for reproducibility using CAPI 3 HEMOGLOBIN(E) procedure and

CAPILLARYS 3 TERA instrument :

Fraction Min Value Max Value SD min SD max CV min CV max SD min SD max CV min CV max

Hb A 44,2 97,3 0,02 0,22 0,0% 0,5% 0,05 0,40 0,0% 0,8%

Hb A2 2,6 6,5 0,02 0,05 0,7% 1,3% 0,05 0,16 1,4% 6,0%

Hb F

Hb S

Hb C

Hb D

Hb E

(*) Total reproducibility includes : within-capillary, between-capillary, between-run and between-day.

8,9 0,10 1,1% 0,15 1,7%

0,7%

0,13 0,7%17,5

26,8

40,6

22,6

Ranges of % tested Between-day Total reproducibility (*)

0,06 0,3% 0,26 1,1%

0,12 0,3% 0,24 0,6%

0,17 1,0%

0,07 0,2% 0,19

510(k) Summary 9

040 9

Interferents Maximum Concentration

Bilirubin 20.6 mg/dL , or 352 µmol/L

Triglycerides 2.2 g/dL , or 25.1 mmol/L

e. Comparison Studies

Method comparison studies were preformed using CAPI 3 HEMOGLOBIN(E) assay using the

CAPILLARYS 3 TERA instrument. The studies were conducted following CLSI, EP09-A2-IR,

Method Comparison and Bias Estimation Using Patient Samples-2nd edition.

The samples were provided by hospitals and laboratories international and United States. A

total of 304 samples (180 without hemoglobin variant /124 with hemoglobin variant) were

analyzed.

The measured values of hemoglobin fractions from both procedures were analyzed by

three regression statistical procedures. The results of regression analysis are tabulated

below:

Site 1:

The levels of hemoglobin fractions were measured in 153 blood samples, including 64

samples with hemoglobin variants, both by electrophoretic separations obtained with the

CAPI 3 HEMOGLOBIN(E) procedure performed with the CAPILLARYS 3 instrument and

a commercially available capillary electrophoresis technique for hemoglobin analysis

(reference).

Normal hemoglobins

Fraction Number of

samples Correlation

coefficient

Ordinary linear

regression Weighted Deming

regression Passing-Bablok

regression Range of Hb % values

CAPI 3 HEMOGLOBIN(E) y-intercept Slope y-intercept Slope y-intercept Slope

Hb A 150 1,000 -0,993 1,010 -0,703 1,007 -0,994 1,010 16,9 - 98,7

Hb A2 148 0,998 0,005 0,986 -0,032 1,000 -0,050 1,000 0,5 - 9,2

Hb F 22 1,000 -0,008 1,009 0,049 0,999 0,027 1,009 0,8 - 83,1

Hemoglobin variants

Fraction Number of

samples Correlation

coefficient

Ordinary linear

regression Weighted Deming

regression Passing-Bablok

regression Range of Hb % values

CAPI 3 HEMOGLOBIN(E) y-intercept Slope y-intercept Slope y-intercept Slope

Hb S 13 1,000 -0,025 1,010 -0,127 1,013 -0,122 1,013 1,8 - 89,7

Hb C 13 1,000 0,099 1,008 0,009 1,009 -0,163 1,018 2,0 - 89,5

Hb D 9 1,000 -0,068 1,015 0,063 1,008 -0,032 1,015 3,3 - 43,7

Hb E 13 1,000 0,183 1,001 -0,054 1,015 -0,080 1,020 5,0 - 86,9

This study demonstrated a perfect correlation between the 2 analysis procedures for the

Hb A, Hb A2, Hb F, Hb S, Hb C, Hb D and Hb E quantitative determination.

All abnormal hemoglobins or abnormal levels of normal hemoglobins detected with the CAPI 3

HEMOGLOBIN(E) procedure performed with the CAPILLARYS 3 instrument were in agreement

with the reference procedure. There was no case observed of false positive, i.e., detection of

an abnormal band or abnormal level of a normal band where no such abnormality existed.

510(k) Summary 10

040 10

Site 2

The levels of hemoglobin fractions were measured in 151 blood samples, including 60 samples with

hemoglobin variants, both by electrophoretic separations obtained with the CAPI 3 HEMOGLOBIN(E)

procedure performed with the CAPILLARYS 3 instrument and a commercially available capillary

electrophoresis technique for hemoglobin analysis (reference).

The measured values of hemoglobin fractions from both procedures were analyzed by

three regression statistical procedures.

Normal hemoglobins

Fraction Number of

samples Correlation

coefficient

Ordinary linear

regression Weighted Deming

regression Passing-Bablok

regression Range of Hb % values

CAPI 3 HEMOGLOBIN(E) y-intercept Slope y-intercept Slope y-intercept Slope

Hb A 148 1,000 -1,928 1,020 -1,553 1,015 -1,379 1,014 15,7 - 98,3

Hb A2 151 0,987 -0,005 1,017 0,004 1,012 0,000 1,000 0,9 - 6,1

Hb F 30 0,999 -0,127 1,009 -0,021 0,965 0,000 1,000 0,5 - 34,3

Hemoglobin variants

Fraction Number of

samples Correlation

coefficient

Ordinary linear

regression Weighted Deming

regression Passing-Bablok

regression Range of Hb % values

CAPI 3 HEMOGLOBIN(E) y-intercept Slope y-intercept Slope y-intercept Slope

Hb S 33 0,999 0,475 1,006 0,105 1,015 0,272 1,011 25,8 - 78,3

Hb C 11 0,997 -1,431 1,069 -1,332 1,066 -1,480 1,067 25,2 - 37,3

Hb E 4 1,000 0,625 1,002 0,630 1,002 0,660 1,001 22,1 - 91,9

This study demonstrated a perfect correlation between the 2 analysis procedures for the

Hb A, Hb A2, Hb F, Hb S, Hb C and Hb E quantitative determination.

All abnormal hemoglobins or abnormal levels of normal hemoglobins detected with the CAPI 3

HEMOGLOBIN(E) procedure performed with the CAPILLARYS 3 instrument were in agreement

with the reference procedure. There was no case observed of false positive, i.e., detection of

an abnormal band or abnormal level of a normal band where no such abnormality existed

The combined number of abnormal hemoglobin variants detected in the combined comparison studies

is as follows: HbS=46, HbC = 24, HbD=9 HbE= 17

All abnormal hemoglobins and abnormal levels of normal hemoglobins detected were in

agreement with the comparative system and clinical diagnosis. There were no observed false

positives (i.e. detection of an abnormal band or abnormal level of a normal band where no such

abnormal existed).

6. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial

equivalence decision.