# K990688: MTM Bioscanner C Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Jun 24, 1999 after 119 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.
10 later devices descend from it; 3 cite it directly.
0 of 11 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
- K023558: PTS Panels Lipid Panel Test Strips (2002), 5 descendants of its own
- K071507: PTS Panels Chol+HDL+Glu Panel Test Strips (2007), 2 descendants of its own
- K090405: Lipidpro System (2009), 1 descendant of its own
- K071593: PTS Panels Chol+HDL Panel Test Strips (2007), 1 descendant of its own
- K160282: SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System (2017), 0 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 whole blood when used with the MTM BioScanner 1000. This system is intended to be used to assist the healthcare professional and the consumer in screening for elevated cholesterol as a risk factor in coronary artery disease.

Source page: https://510kreport.com/device/K990688
Methodology: https://510kreport.com/methodology