MTM BIOSCANNER K TEST STRIPS

K981865 · Polymer Technology Systems, Inc. · JMK · Feb 26, 1999 · Clinical Chemistry

Device Facts

• Record ID: K981865
• Device Name: MTM BIOSCANNER K TEST STRIPS
• Applicant: Polymer Technology Systems, Inc.
• Product Code: JMK · Clinical Chemistry
• Decision Date: Feb 26, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1380
• Device Class: Class 1

Intended Use

The MTM Bio Scamer K Test Strip is intended for the in vitro digginatic quantitative screenin a for Ketones in whole blood, servin and plasme in physicians' office laboratories and at bedside in aeute and convalescent care facilities to screen for ketosis and Diabetic Ketoandesis

Device Story

MTM BioScanner K Test Strips are in vitro diagnostic test strips used for quantitative screening of ketones. Input consists of whole blood, serum, or plasma samples. Used in physician office laboratories and bedside in acute or convalescent care facilities. Healthcare providers use the strips to screen patients for ketosis and diabetic ketoacidosis. Output provides quantitative ketone levels to assist in clinical assessment of metabolic status.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic test strip for quantitative ketone measurement. Form factor is a disposable test strip. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for in vitro diagnostic quantitative screening of ketones in whole blood, serum, and plasma. Used in physician office laboratories and acute/convalescent care facilities to screen for ketosis and diabetic ketoacidosis.

Regulatory Classification

Identification

A hydroxybutyric dehydrogenase test system is a device intended to measure the activity of the enzyme alpha-hydroxybutric dehydrogenase (HBD) in plasma or serum. HBD measurements are used in the diagnosis and treatment of myocardial infarction, renal damage (such as rejection of transplants), certain hematological diseases (such as acute leukemias and megaloblastic anemias) and, to a lesser degree, liver disease.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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FEB 26 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K981865

Trade Name: MTM BioScanner K Test Strips Regulatory Class: I Product Code: JMK Dated: January 4, 1999 Received: January 6, 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 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 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 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

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510(k) Number (if known): Device Name: MTm Bio Scanner K Test Strips Indications For Use:

The MTM Bio Scamer K Test Strip is intended for the in vitro digginatic quantitative screenin a for Ketones in whole blood, servin and plasme in physicians' office laboratories and at bedside in aeute and convalescent care facilities to screen for ketosis and Diabetic Ketoandesis

Sean Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices
510(k) Number K981865

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)