MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON

K972669 · Polymer Technology Systems, Inc. · CGA · Jan 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K972669
• Device Name: MTM BIOSCANNER 1000 TEST SYSTEM CONSISTING OF MTM BIOSCANNER 1000 METER, MTM BIOSCANNER G TEST STRIP, NORMAN GLUCOSE CON
• Applicant: Polymer Technology Systems, Inc.
• Product Code: CGA · Clinical Chemistry
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2

Intended Use

Polymer Technology Systems, Inc. intends to introduce into commercial distribution the MTM BioScanner 1000 Test System for the quantitative determination of glucose in human whole blood when used with the MTM BioScanner G Test Strip. This Monitoring System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

Device Story

MTM BioScanner 1000 Test System measures glucose levels in human whole blood; utilizes MTM BioScanner G Test Strips. System provides quantitative glucose results to assist patients and healthcare professionals in diabetes management. Used in clinical or home settings; operated by patients or healthcare providers. Output informs diabetes management decisions; facilitates patient monitoring.

Technological Characteristics

In vitro diagnostic system for quantitative glucose determination in whole blood. Uses specific test strips (MTM BioScanner G).

Indications for Use

Indicated for quantitative determination of glucose in human whole blood to assist patients and healthcare professionals in diabetes management.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 22 1998

Margo Enright Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, Indiana 46268

Re: K972669 MTM BioScanner 1000 Test System Requlatory Class: II Product Code: CGA November 6, 1997 Dated: November 7, 1997 Received:

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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include reguirements 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 requlations 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 requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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.

{1}------------------------------------------------

Page 2

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 the regulacion chercica, "Mabbanding by rozectioneral 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/dsmamain.html".

Sincerely yours,
Steven Gutman

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

{2}------------------------------------------------

## APPENDIX B

## INDICATIONS OF USE

Polymer Technology Systems, Inc. intends to introduce into commercial distribution the MTM BioScanner 1000 Test System for the quantitative determination of glucose in human whole blood when used with the MTM BioScanner G Test Strip. This Monitoring System is intended to be used to assist the patient and healthcare professional in the management of diabetes.

(Division Sign-Off) (Division Oigh-Off)
Division () 510(k) Number -

Prescription use