MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)

K993377 · Polymer Technology Systems, Inc. · NAQ · Jan 13, 2000 · Clinical Chemistry

Device Facts

• Record ID: K993377
• Device Name: MTM BIOSCANNER HDL TEST STRIPS, OVER THE COUNTER (OTC)
• Applicant: Polymer Technology Systems, Inc.
• Product Code: NAQ · Clinical Chemistry
• Decision Date: Jan 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the BioScanner. This system is intended to be used to assist the healthcare professional and individuals in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease.

Device Story

System consists of MTM BioScanner HDL Test Strips used with BioScanner meter. Device performs in-vitro quantitative analysis of HDL cholesterol from whole blood samples. Used by healthcare professionals and individuals for screening coronary artery disease risk. Provides quantitative HDL cholesterol levels to assist in clinical decision-making regarding cardiovascular health.

Technological Characteristics

In-vitro diagnostic test strip for use with BioScanner meter. Quantitative enzymatic assay for HDL cholesterol in whole blood.

Indications for Use

Indicated for in-vitro quantitative measurement of HDL cholesterol in whole blood to screen for decreased HDL levels as a risk factor for coronary artery disease. Intended for use by healthcare professionals and individuals (OTC).

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 1 3 2000

Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, Indiana 46268

Re: K993377

> Trade Name: MTM BioScanner HDL Test Strips, Over the Counter (OTC) Use Regulatory Class: I reserved Product Code: NAQ Dated: November 23, 1999 Received: November 24, 1999

Dear Ms. Enright:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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POLYMER TECHNOLOGY

Indications for Use

http://www.fda.gov/cdrh/ode/indicate.html

## Center for Devices and Radiological Health . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Page , of

510(k) Number (if known):

BioScanner HDL Cholesterol Test Strips (OTC use) Device Name: __

Indications for Use:

The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation of HDL Cholesterol in whole blood when used with the BioScanner. This system is intended." to be used to assist the healthcare professional and individuals in screening for decreased levels of HDL Cholesterol as a risk factor in coronary artery disease.

Jean Cooper

(Division Sign-Off)
Division of Clinical Laboratory vices

K993377

k) Number

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Concurence of CDRH, Office of Device Evaulation (ODE)

CTC✓

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