POLY-CHEM GLUCOSE

K020852 · Polymedco, Inc. · CFR · Jul 3, 2002 · Clinical Chemistry

Device Facts

• Record ID: K020852
• Device Name: POLY-CHEM GLUCOSE
• Applicant: Polymedco, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Jul 3, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Polymedco Poly-Chem Glucose test system is an in vitro diagnostic procedure intended to measure glucose quantitatively in human serum and plasma on the Poly-Chem analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of the pancreatic isle cell carcinoma.

Device Story

The Polymedco Poly-Chem Glucose test is an in vitro diagnostic reagent system designed for use on the Poly-Chem analyzer. It measures glucose levels in human serum and plasma samples. The system is intended for clinical laboratory use by trained personnel to assist in the diagnosis and management of carbohydrate metabolism disorders. Results are provided to clinicians to inform clinical decision-making regarding patient metabolic status and disease management.

Clinical Evidence

No clinical data provided; substantial equivalence is based on performance characteristics of the glucose test system.

Technological Characteristics

In vitro diagnostic reagent system for quantitative glucose measurement. Designed for use on the Poly-Chem analyzer. Operates via standard biochemical assay principles for glucose detection in serum and plasma.

Indications for Use

Indicated for quantitative measurement of glucose in human serum and plasma for diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL -3 2002

Ms. Helen Landicho, RAC Director Regulatory Affairs Polymedco, Inc. 510 Furnance Dock Road Cortlandt Manor, NY 10567

Re: k020852

Trade/Device Name: The Polymedco Poly-Chem Glucose Test Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: May 30, 2002 Received: May 31, 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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## SECTION 12.0 INDICATIONS FOR USE STATEMENT

510(k) Number: K020852

Device Name: The Polymedco Poly-Chem Glucose Test

Indications For Use:

The Polymedco Poly-Chem Glucose test system is an in vitro diagnostic procedure intended to measure glucose quantitatively in human serum and plasma on the Poly-Chem analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of the pancreatic isle cell carcinoma.

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Dean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020852

V Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use