# K993377: MTM Bioscanner HDL Test Strips, Over the Counter (Otc)

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Jan 13, 2000 after 107 days
- Product code: NAQ (Lipoprotein, High Density, Hdl, Over The Counter)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
12 later devices descend from it; 2 cite it directly.
0 of 13 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
- K060617: PTS Panels HDL Cholesterol Test Strips (2006), 5 descendants of its own
- 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

## Indications for use
The MTM BioScanner HDL Test Strip is intended for the in-vitro-diagnostic quantitation A of HDL Cholesterol in whole blood when used with the BioScanner. This system Is intended .« to be used to assist the healthcare professional and individuals in screening for decreased Jevels of HDL Cholesterol as a risk factor in coronary artery disease.

Source page: https://510kreport.com/device/K993377
Methodology: https://510kreport.com/methodology