MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220

K981493 · Polymer Technology Systems, Inc. · CHH · Jul 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981493
• Device Name: MTM BIOSCANNER C TEST STRIPS MODEL NUMBER BSA 200, BSA 210, BSA 220
• Applicant: Polymer Technology Systems, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Jul 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Intended Use

The MTM BioScanner C Test Strip is intended for the in-vitro diagnostic quantitation of total Cholesterol in human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated cholesterol as a risk factor in coronary artery disease.

Device Story

The MTM BioScanner C Test Strip is an in-vitro diagnostic component used with the MTM BioScanner 1000 system. It processes human whole blood samples to provide quantitative measurements of total cholesterol. The system is designed for use by healthcare professionals to screen for elevated cholesterol levels, which serve as a risk factor for coronary artery disease. The device provides clinicians with objective data to aid in patient risk assessment and clinical decision-making regarding cardiovascular health.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

In-vitro diagnostic test strip for quantitative cholesterol measurement in whole blood. Designed for use with the MTM BioScanner 1000 system. Class I device (Product Code: CHH).

Indications for Use

Indicated for in-vitro diagnostic quantitative measurement of total cholesterol in human whole blood to assist healthcare professionals in screening for elevated cholesterol as a risk factor for coronary artery disease.

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

## Jul 22 1998

Margo Enright Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, Indiana

Re : K981493 Trade Name: MTM Bioscanner C Test Strips Model Number BSA 200, BSA 210, BSA 220 Requlatory Class: I Product Code: CHH Dated: June 12, 1998 Received: June 15, 1998

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 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, listinq 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 Requlations.

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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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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) Number (if known): | K981493 |
|---------------------------|------------------|
| Device Name: | MTM Bioscanner C |

Test Steps## Indications For Use:

The MTM BioScanner C Test Strip is intended for the in-vitro diagnostic quantitation of total Cholesterol in human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated cholesterol as a risk factor in coronary artery disease.

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

**Concurrence of CDRH, Office of Device Evaluation (ODE)**

*Bivision Sign Off)*

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K981495

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use_

(Optional Format 1-2-96)