(190 days)
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.
Not Found
This document is a 510(k) clearance letter from the FDA for the MTM BioScanner 1000 Test System, a device for quantitatively determining glucose in human whole blood. It confirms the device's substantial equivalence to existing devices. However, this document does not contain the specific details about acceptance criteria, device performance, or study methodology that you requested.
The letter states that the device is for "quantitative determination of glucose in human whole blood when used with the MTM BioScanner G Test Strip" and "is intended to be used to assist the patient and healthcare professional in the management of diabetes." To provide the information you asked for, I would need access to the actual 510(k) submission (K972669) documents, which would include the study details.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.
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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.
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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 (770) 488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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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
§ 862.1345 Glucose test system.
(a)
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.(b)
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.