# K981493: MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Jul 22, 1998 after 86 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 4 cite it directly.
0 of 16 devices 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.

## Most influential descendants
- K013173: Bioscanner Plus; Lipid Panel Test Strips (2001), 9 descendants of its own
- K022898: PTS Panels Lipid Panel Test Strips (2002), 7 descendants of its own
- K014099: Bioscanner Plus (2001), 7 descendants of its own
- K140068: Cardiochek Plus Test System, Cardiochek Home Test System (2015), 6 descendants of its own
- K071507: PTS Panels Chol+HDL+Glu Panel Test Strips (2007), 2 descendants of its own

## Recalls of this device
- Apr 2, 2009 · Not classified · Z-0871-2010: The memory chip was coded with incorrect product information.

## Indications for use
The MTM BioScanner C Test Strip is intended for the in-vitro diagnostic quantitation of total Cholesterol in human whole blood when used with the MTM BioScanner 1000. This System is intended to be used to assist the healthcare professional in screening for elevated cholesterol as a risk factor in coronary artery disease.

Source page: https://510kreport.com/device/K981493
Methodology: https://510kreport.com/methodology