Declaration of Conformity

According to annex III of the Council Directive 98/79/EEC on in vitro diagnostic medical device

We,

Pointe Scientific, Inc.5449/ Research DriveCanton MI48188 USATel: +1.734.487-8301Fax: +1.734.483-1592E-mail: tsheehan@pointescientific.com

Declare under our sole responsibility that the following in vitro diagnostic medical devices otherthan those covered by annex II and devices for performance evaluation:

See annex list of products

Meet the provisions of the Council Directive 98/79/EEC concerning medical devices which applyto them.

Undersigned declares to fulfi II the obligations imposed by Annex III section 2 to 5:- availability of the technical documentation set in Annex III (section 3), allowing the

assessment of conformity of the product with the requirements of the Directive.- the manufacturer shall take necessary measures to ensure that the manufacturing process

follows the principles of quality assurance as appropriate for the products manufactured(Annex III section 4).

- the manufacturer shall institute and keep up to date a systematic procedure to reviewexperience gained from devices in the post-production phase and to implement appropriatemeans to apply any necessary corrective actions (Annex III section 5).

Conformity assessment was performed according to Article 9 (7) and Annex III, section 3.

Our current Quality System is formatted to international standards and we are currentlyseeking ISO 13485:2003 certification. We expect this process to be completed by late, 2007.

Signatory established within the EU who has been empowered to enter into commitments on ourbehalf:

Pointe Scientific, Inc.5449 Research Dr.Canton, MI48188USAPhone: +1.734.487.8301Fax: +1.734.483.1592

Email: rjamison@pointescientific.comMr. Ron JamisonQA/Technical Service ManagerSignature:

iL)L~

European Authorized Representative (E.A.R.)Obelis S.A.34 Av. De Tervuren, bte 44

B-1040 Brussels, BelgiumPhone: +32.2.732.59.54

Fax: +32.2.732.60.03

E-mail: mail@obelis.net

Mr. Gideon Elkayam

General Manager ~

Signature: ~

~

G. ELKAYAMAdmlnlstrateur~

Obelis 5.8. O.E.A.R.C.avo de Tervuren 34, Bte 441040 Brussels - BELGIUM

Tel. +32.2.732 59 54 - Fax +32.2.732 60 03

SCIENTIFIC INSTITVTE OF PUBLICHEAL.TH

ClINICAL. BIOLOGYDEPARTMENT

~mailfrom

your references

our references: IVDOO4-05date: 17/0112005

Dear Mr. Ohn,

tel. : 021642.55.21fax: 021642.56.45contact person: Dr. Pharm. J.C. Ubeere-mail: jean-elaude.libeer@iph.fgov.becontact person: Dr. A. Van Nerem. DVMe-mail: Anne.VanNerom@iph.fgov.be

Mr. M. Ohn

Obelis SAAv. De Tervueren, 34 Bte 44B-1040 Bruxelles

Please find enclosed the original notification form for the GE marked in vitro diagnostic medicaldevices, notified to the Belgian Competent Authority. This notification form is an acknowledgementof your declaration that the in vitro diagnostic medical devices, mentioned hereunder. fully complywith the Directive 98/78 of the European Parliament and of the Council. Be aware that it is anoffence to place on the market non-complying devices bearing the GE marking. This form does notrepresent an accreditation or approval by the Belgian Competent Authority.

Please inform us of any changes (change of company information, change of address, significantchange of product, change of certificate) and of the discontinuation of the product

In accordance with the dispositions of the directive 98179, you have the obligation to send a copy ofyour notification request to the Competent Authorities of the other EU member states, as long asthe European database does not exist. The electronic formats of the notification forms, completedwith the registration number, were sent to you. An updated list of the Competent Authorities isavailable on our website: http://WoN.N.iph.fgov.be/ClinBiol/IVDfile/Nolificalion.pdf.

Sincerely yours.

Dr. A. Van NeromIVD Competent Authority

Federal Public Service

Healll1. Food Chain Securityand Envirooment

Dr. J.G. UbeerDepartment Head

Address:Juliette Wytsmanstraat 148-1050 BRUSSELS - BELGIUMTel: ++ 32flJ642.51.11Fax:++ 32flJ642.50.01

_____ hnp:llwww.iph.fgov.be

SCIENTIFIC INSTITUTE Of PUBL.ICHEALTH

a.INICAL BIOLOGYDEPARTMENT

our references: IVD004-05dale'17/01/2005

tel. : 021642.55.21fax. 021642.56.45contact person: Dr. Pharm. J.C. Libeere-mail: jean-claude.libeer@iph.fgov.becontact person: Dr. A. Van Nerom, DVMe-mail: Anne.VanNerom@iph.fgov.be

Re: notification of IVD products according to the directive 98/79

Competent Authority: BEfCA02

Manufacturer: Pointe Scientific, Inc., 5449 Research Drive, Canton MI 48188, USA

Authorized representative: OBELIS SA, Av. de Tervuren 34 Bte 44, B-1 040, Brussels, Belgium

Date of registration: 17/01f2005

Type of IVD: reagents for professional use

IVD EDMS code Registration number

AST ref HA761 , A7561 , A7560 1101011000 BE-CA02-212-03Auto LDL 1101012100 BE-CA02-213-03Auto HDL 1102071500 BE·CA02·214·03Auto HDULDL Calibrator 1150030100 BE-CA02-215-03

113-hvdroxvbutvrate 11 0201 9000 BE-CA02-216-03113-hvdroxvbutvrate Controls 11 50029000 BE-CA02-217-03Bilirubin Calibrator 11 50030200 BE·CA02·218·03BUN ref B7550, B7551, HB752, B7552 11 0201 0400 BE-CA02·219·03Bun Standard 11 50030300 BE·CA02·220·03Calcium (ref Cl508, C7529, HC902, C7503 11 0301 0300 BE·CA02·221·03Calcium Standard 11 50030300 BE-CA02-222-03Chemistrv calibrator 1150030100 BE-CA02-223-03Chemistrv Control Level I, II 11 5001 0200 BE·CA02·224·03Chloride 1103010400 BE·CA02·225·03Chloride Standard 11 50030300 BE-CA02-226·03Cholesterol ref HC710, C7509, C75101 1102010500 BE-CA02-227-03Cholesterol Calibrator 11 50030200 BE·CA02·228·03Cholesterol Standard 11 50030300 BE·CA02·229·03Cholesterol-HDL Standard 11 50030300 BE·CA02·230·03CK ref C7512, HC722, C7522 1101011300 BE·CA02·231·03CK-MB 1101011400 BE·CA02·232·03CK-MB Control Set 11 50029000 BE-CA02-233-03CO2 1103010200 BE·CA02·234·03C02 Standard 11 50030300 BE-CA02-235-03Cortisol 1206020400 BE-CA02-236-03Creatinine ref C7539, HC739) 11 0201 0700 BE·CA02·237·03

Federal Public Service Address:Julielle Wytsmanstraal14

Health. Food Chain Security 6-1050 BRUSSELS - BELGIUMand Environment Tel: ++ 3212/642.51.11

Fax:++ 3212/642.50.01_____ htlp:/Iwww.iph.fgov.be

• 1 •

Type of IVD: reagents for professional use: continued

CRPHS 1211010900 BE-CA02-238-03CRP Calibrator set 11 50030200 BE·CA02·239·03CRP Control set 11 50029000 BE·CA02-240-03Direct Bilirubin ref B7538, HB936} 11 0201 0300 BE-CA02-241-03Estradiol 120501 0300 BE-CA02-242-03Free Thyroxine 120401 0200 BE-CA02-244-03Free Triiodothvonine 1204010100 BE-CA02-245-03Fructosamine 1102011000 BE-CA02-246-03Fructosamine control set 1150029000 BE-CA02-247-03FSH 120501 0400 BE-CA02-248-03G6PO 1101019000 BE-CA02-249-03GGT (ref G7570, HG959, G7571 1101011600 BE-CA02-250-03GIUCO~~ {ref G7518, HG920, G7517,G7519, 1102011300 BE·CA02-251-03G7521Glucose Standard 11 50 03 0300 BE-CA02-252-03Glvcohemoalobin 1102011400 BE-CA02-253-03Glvcohemoalobin A1c 120601 0600 BE-CA02-254-03Glvcohemoolobin Control Set 11 50 02 9000 BE·CA02-255-03Glvcohemoolobin Standard 11 50 03 0200 BE-CA02-256-03HBOH 1101011800 BE-CA02-257-03HCG 1205020500 BE-CA02-258-03HDL Cholesterol Preci itatin Rea en! Set 1102071500 BE-CA02-259-03HOL 11 50030300 BE-CA02-260-03Hemo lobin 1301020100 BE·CA02·261·03Hemo lobin Standard 11 50030200 BE-CA02-262-03Hemo lobin Control Set 11 5002 9000 BE-CA02-263-03loE 1202010200 BE-CA02-264-03IronlTlBC 1102011600 BE-CA02-265-03Iron 1102011600 BE-CA02-266-03Iron Standard 11 50030300 BE-CA02-267-03Lactate 1102011800 BE-CA02-268-03Lactate Standard 11 5003 0300 BE-CA02-269-03LDH (ref HL956, L7535, L7572l 1101012000 BE-CA02-270-03LH 1205010500 BE-CA02-271-03Lioase 1101012300 BE-CA02-272-03Lioase Standard 11 50030200 BE·CA02·273·03Lioid Control Set 11 50 02 0200 BE-CA02-274-03Liooorotein fal 1201049000 BE-CA02-275-03Ma nesium Standard 11 5003 0300 BE-CA02-276-03Ma nesium ref M7527, HM929 1103010700 BE-CA02-277-03Microalbumin 1102010100 BE-CA02-278-03Microalbumin Calibrator Set 11 50 03 0200 BE·CA02·279·03Microalbumin Control Set 11 50 90 0200 BE-CA02-280-03Micro rotein 1102013000 BE-CA02-281-03Microprotein Standard 1150030300 BE-CA02-282-03Phosphorus ref P7516, HP916 1103010800 BE-CA02-283-03Phosphorus Standard 1150030300 BE-CA02-284-03Potassium 1103010900 BE-CA02-285-03Potassium Calibrator 1150030200 BE-CA02-286-03Prooesterone 120501 0600 BE-CA02·287·03Prolactin 120501 0800 BE-CA02-288-03RF 1211011000 BE-CA02-290-03RF Calibrator Set 1150030200 BE-CA02-291-03Sodium 1103011000 BE-CA02-292-03Total Bilirubin ref 87576, HB979) 1102010300 BE-CA02-293-03Testosterone 120501 1000 BE-CA02-294-03

Federal Public Service Address:Juliette Wytsmanstraat14

Health. Food Chain Security B-l050 BRUSSELS· BELGIUMand Environment Tel' .... 32/2/642.51.11

Fax:++ 32/2/642.50.01_____ http://www.iph.fgov.be

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Type of IVO: reagents for professional use: continued

Thvroid Stimulatinq Hormone 1204011100 BE-CA02-295-03Total Protein (ref T7528, HT928) 1102013000 BE-CA02-296-03Total Protein Standard 1150030300 BE·CA02-297-03Total Thyroxine 120401 0700 BE-CA02-298-03Trialyceride refT7531,HT732, T7532 1102013100 BE-CA02-299-03Trialvceride Standard 1150030300 BE-CA02-3OO-D3Triiodothyronine 1204010500 BE-CA02-301-Q3Ultra Sensitive Thyroid StimuJatino Hormone 120401 9000 BE-CA02-302-D3Uric Acid ref U7580, HU982,U75811 11 02 01 320D BE-CA02-303-03Uric Acid Standard 11 50 03 0300 BE-CA02-304-D3Micro rotein Control Set 11 50 90 900D BE-CA02-305-03

I; rotein b 1201040300 BE-CA02-306-D3oli rotein a calibrators 1250 0180 OD BE·CA02-307-03

\OOliDOprotein A1 120104 010D BE-CA02-308-D3Am~ase HA965.A7564) 1101010700 BE-CA02-309-D3A1cohoVAmmonia Control 1250 90 9000 BE-CA02-31Q-03ASO Assav 1211010400 BE-CA02·311.Q3ASO multicalibrator set 12 SO 018000 BE·CA02·312.Q3Ammonia standard SOD, 100) 11 50 03 0300 BE-CA02-313-03Ammonia 11 0301 010D BE-CA02-314-D3ALT ref A7526. HA726, A7525) 1101010300 BE-CA02-315-03Alkaline Phosphatase (ref A7516, HA716, 1101010500 BE-CA02-316.Q3A7505Alcohol Standard 11 50 03 0300 BE-CA02-317-D3Alcohol 11 02019000 BE-CA02-318-D3Albumin ref HA901, A7S02) 11 0201 0100 BE-CA02-319-03Albumin Standard 11 SO 03 0300 BE-CA02-320-D3Aooliooorotein a (Loa 1201042100 BE-CA02-321-D3Aooliooorotein B Calibrators 11 50 03 0200 BE-CA02-322-D3Creatinine standard 11 50030300 BE-CA02-482-03Acid Phosohatase 11 01 01 0200 BE·CA02·483.Q3ISE standard 1 solution 110404 BE-CA02-723-04ISE Standard Hi h 11 0404 BE-CA02-724-04ISE Standard 2 11 0404 BE-CA02-725-04ISE Standard Low 11 0404 BE-CA02-726-04Random Access Solution 110404 BE-CA02-727-04ISE Reference Solution 110404 BE-CA02-728-04Cell Wash 110404 BE-CA02-729-04Precision Test Ove 11 0404 BE-CA02-73O-04Pointe 180 II spectrophotometer GMDN 36411 BE-CA02-004-05Pointe 180 PLUS spectrophotometer GMDN 36411 BE-CA02-005-05Stat Fax 3200 microliter plate GMDN 36411 BE-CA02·006-05spectrophotometerPointe 180 SR microstrip reader GMDN 36411 BE-CA02·007·05

Dr. A. Van NeromIVD Competent Authority

This notification contains 3 pages and replaces the certificate issued 15-09·2004

Federal Public Service Address:Juliette WytSmanstraal14

HeaJIh. Food Chain Security 8-1050 BRUSSELS - BELGIUMand Environment Tel: H 32121642,51.11

Fax:H 3212J642.5O.G1____ _ http://WMY.iph.lgov.be

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