(190 days)
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Not Found
No
The summary describes a standard glucose monitoring system and lacks any mention of AI, ML, or related concepts.
No
The device is described as a "Test System" for the "quantitative determination of glucose" to "assist in the management of diabetes." It is a diagnostic tool used for monitoring, not a device that directly treats or cures a disease.
Yes.
The device performs "quantitative determination of glucose in human whole blood" to "assist the patient and healthcare professional in the management of diabetes," which is a diagnostic purpose.
No
The device description is not found, but the intended use clearly states it uses a "Test System" and "Test Strip" for quantitative determination of glucose in human whole blood, implying hardware components are involved.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of glucose in human whole blood". This involves testing a biological sample (whole blood) outside of the body (in vitro) to obtain diagnostic information (glucose levels for diabetes management).
- Sample Type: The device uses "human whole blood", which is a biological specimen.
- Purpose: The purpose is to "assist the patient and healthcare professional in the management of diabetes", which is a medical condition.
These are all key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
CGA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
human whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
patient and healthcare professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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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.
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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