HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL

K063209 · Thermo Electron OY · LCP · Mar 21, 2007 · Hematology

Device Facts

• Record ID: K063209
• Device Name: HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
• Applicant: Thermo Electron OY
• Product Code: LCP · Hematology
• Decision Date: Mar 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The hemoglobin A1c (HbA1c) test system with associated calibrators and controls is intended for quantitative in-vitro diagnostic determination of the hemoglobin A1c (HbA1c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbA1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Device Story

HbA1c Test System consists of reagents, calibrators, and controls for quantitative measurement of HbA1c in human whole blood. Device operates on T60 Clinical Chemistry Analyzers. Used in clinical laboratory settings by trained personnel. Input is whole blood sample; system performs biochemical assay to determine HbA1c concentration as percentage of total hemoglobin. Output is numerical HbA1c value used by clinicians to assess long-term glycemic control in diabetic patients. System facilitates monitoring of diabetes management.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics of the assay system.

Technological Characteristics

Quantitative immunoturbidimetric assay. Reagents: sheep anti-HbA1c antibodies, HbA1c-polyhapten, phosphate buffer. Calibrators/controls: lyophilized human/sheep blood-based hemolysate. Detection: bichromatic turbidimetric measurement. Traceability: IFCC reference method and DCCT/NGSP master equation. Storage: 2-8°C. Software: embedded in T60 Clinical Chemistry Analyzer for automated calculation of HbA1c% and DCCT/NGSP conversion.

Indications for Use

Indicated for quantitative in-vitro diagnostic determination of HbA1c concentration in human whole blood to monitor long-term glucose control in individuals with diabetes mellitus.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Päivi Sormunen Thermo Electron Oy Ratastie 2 P.O. Box 100 FIN-01621 Vantaa Finland

MAR 2 1 2007

Re: k063209 Trade Name: HbA1c Test System, Calibrator, Control normal, and Control abnormal Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, KRZ, JJX Dated: February 07, 2007 Received: March 09, 2007

Dear Mr. Sormunen:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): _ k063209

## Device Name: HbA1c Test System, HbA1c Calibrators, HbA1c Control Normal, HbA1c Control Abnormal

Indications For Use:

The hemoglobin A1c (HbA1c) test system with associated calibrators and controls is intended for quantitative in-vitro diagnostic determination of the hemoglobin A1c (HbA1c) concentration as a percentage of total hemoglobin in human whole blood using T60 Clinical Chemistry Analyzers. Measurement of percent HbA1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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K063209