# K990247: MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: May 28, 1999 after 122 days
- Product code: LBR (Ldl & Vldl Precipitation, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
16 later devices descend from it; 2 cite it directly.
0 of 17 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
- K060617: PTS Panels HDL Cholesterol Test Strips (2006), 5 descendants of its own

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

Source page: https://510kreport.com/device/K990247
Methodology: https://510kreport.com/methodology