# K983860: MTM Bioscanner K Test Strips, Cat # BSA610

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Dec 27, 1999 after 420 days
- Product code: JMK (Acid, Alpha-Ketobutyric And Nadh (U.V.), Hydroxybutyric Dehydrogenase)
- Device class: 1
- Regulation: 21 CFR 862.1380
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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.

Source page: https://510kreport.com/device/K983860
Methodology: https://510kreport.com/methodology