POLYMEDCO HBA1C TEST

K020532 · Polymedco, Inc. · LCP · Apr 24, 2002 · Hematology

Device Facts

• Record ID: K020532
• Device Name: POLYMEDCO HBA1C TEST
• Applicant: Polymedco, Inc.
• Product Code: LCP · Hematology
• Decision Date: Apr 24, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Intended Use

The Polymedco HbA1c assay used on the Cobas Mira, Poly-Chem, Olympus, Hitachi and Dimension analyzers is an in vitro diagnostic assay for the quantitative determination of percent HbA1c in anticoagulated whole blood. Measurements of percent HbA1c are effective in monitoring long-texm glucose control in individuals with diabetes mellitus.

Device Story

Polymedco HbA1c Test is an in vitro diagnostic assay for quantitative measurement of percent HbA1c in anticoagulated whole blood samples. Designed for use on clinical chemistry analyzers including Cobas Mira, Poly-Chem, Olympus, Hitachi, and Dimension systems. Operated by laboratory professionals in clinical settings. Assay provides numerical HbA1c percentage values; results assist clinicians in assessing long-term glycemic control in diabetic patients. Device facilitates monitoring of diabetes management through standardized laboratory testing.

Technological Characteristics

In vitro diagnostic assay for quantitative determination of HbA1c. Designed for use on automated clinical chemistry analyzers (Cobas Mira, Poly-Chem, Olympus, Hitachi, Dimension).

Indications for Use

Indicated for the quantitative determination of percent HbA1c in anticoagulated whole blood to monitor long-term glucose control in individuals diagnosed 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Food and Drug Adminis 098 Gaither Road Rockville MD 20850

Ms. Helen Landicho, RAC Director, Regulatory Affairs Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, New York 10567

APR 24 2002

Re: k020532

Trade/Device Name: Polymedco™ HbA1c Test Regulation Number: 21 CFR § 864.7470 Regulation Name: Glycated Hemoglobin Assay Regulatory Class: II Product Code: LCP Dated: February 5, 2002 Received: February 19, 2002

Dear Ms. Landicho:

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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) submission

Polymedco HbA1c Test

## SECTION 12.0 INDICATIONS FOR USE STATEMENT

510(k) Number: _ 020532

Device Name:

Indications For Use:

The Polymedco HbA1c assay used on the Cobas Mira, Poly-Chem, Olympus, Hitachi and Dimension analyzers is an in vitro diagnostic assay for the quantitative determination of percent HbA1c in anticoagulated whole blood. Measurements of percent HbA1c are effective in monitoring long-texm glucose control in individuals with diabetes mellitus.

Josephine Bautista

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K020532

(PLEASE NO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

V Prescription Use (Per 21 CFR 801.109) OR

## Over-The-Counter Use