HEMOGLOBIN A1C REAGENT SET

K031539 · Pointe Scientific, Inc., · LCP · Aug 6, 2003 · Hematology

Device Facts

• Record ID: K031539
• Device Name: HEMOGLOBIN A1C REAGENT SET
• Applicant: Pointe Scientific, Inc.,
• Product Code: LCP · Hematology
• Decision Date: Aug 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

This product is to be used for the quantitative determination of hemoglobin A1c in human blood. The determination of hemoglobin A1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

Device Story

Hemoglobin A1c Reagent Set is an in vitro diagnostic assay for quantitative measurement of hemoglobin A1c in human blood samples. Used in clinical laboratory settings to assess glycemic control in diabetic patients; provides historical glucose level indication over 4-8 weeks. Higher A1c values correlate with poorer glycemic control. Healthcare providers use results to monitor diabetes management and adjust treatment plans. Device functions as a chemical reagent set for laboratory analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent set for quantitative hemoglobin A1c assay. Chemical-based diagnostic test.

Indications for Use

Indicated for quantitative determination of hemoglobin A1c in human blood to evaluate glycemic control in patients with diabetes.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/0/Picture/2 description: The image is a black and white circular seal. The seal contains the symbol of the U.S. Department of Health and Human Services in the center. The text "U.S. Health & Human Services" is written around the perimeter of the circle.

AUG - 6 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. William F. Walters, Jr. V.P. - Technical Operations Pointe Scientific, Inc. 1025 John A Papalas Drive Lincoln Park, MI 48146

Re: k031539

> Trade/Device Name: Hemoglobin A 1 c Reagent Set Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: May 02, 2003 Received: May 16, 2003

Dear Mr. Walters:

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 http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510 (k) Number (if known): Unknown at this time

Device Name: Hemoglobin A1c Reagent Set

Indications for use:

This product is to be used for the quantitative determination of hemoglobin A1c in human blood. The determination of hemoglobin A1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over the Counter Use

Jean Cooper

**Division Sign-Off**

(Optional Format 1-2-96)

ro Diagnostic Device fice of In Vit tion and l

510(k) K 031539