(420 days)
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No
The summary describes a test strip for measuring ketones in blood, which is a chemical assay and does not typically involve AI/ML. There are no mentions of AI, ML, image processing, or data analysis methods that would suggest the use of these technologies.
No
The device is a diagnostic tool used to measure ketones, not to treat a condition or disease.
Yes
The device is intended for the "quantitative measurement of ketones in capillary whole blood," which is a diagnostic activity used to determine the presence or concentration of a substance in the body for medical purposes.
No
The device is described as "MTM BioScanner K Test Strips," which are physical test strips used for quantitative measurement. This indicates a hardware component, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "quantitative measurement of ketones in capillary whole blood". This involves testing a biological sample (blood) in vitro (outside the body) to obtain diagnostic information (ketone levels).
- Sample Type: The device uses "capillary whole blood", which is a biological specimen.
- Purpose: The purpose is to measure a substance (ketones) in the sample for diagnostic purposes (determining ketone levels).
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MTM BioScanner K Test Strips are intended for the quantitative measurement of ketones in capillary whole blood in physicians office labs and at the bedside by professionals and at home by lay users.
Product codes
JMK
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
capillary whole blood
Indicated Patient Age Range
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Intended User / Care Setting
physicians office labs and at the bedside by professionals and at home by lay users.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1380 Hydroxybutyric dehydrogenase test system.
(a)
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.(b)
Classification. Class I (general controls). The device 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 shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEC 27 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, Indiana 46268
Re: K983860 Trade Name: MTM BioScanner K Test Strips Regulatory Class: II Product Code: JMK Dated: July 15, 1999 Received: July 16, 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 (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 (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 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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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): x 98 3860
Device Name: MTM BioScanner K Test Strips
Indications For Use:
MTM BioScanner K Test Strips are intended for the quantitative measurement of ketones in capillary whole blood in physicians office labs and at the bedside by professionals and at home by lay users.
Ian Cooper
(Division Sign-Off)
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983860
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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)