# K060617: PTS Panels HDL Cholesterol Test Strips

- Pathway: 510(k) (Special)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Apr 5, 2006 after 28 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
Longest line of descent: 1 generation back to K990247 (1999). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990247: MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470, Polymer Technology Systems, Inc. (1999) Summary page 2.
- K993377: MTM Bioscanner HDL Test Strips, Over the Counter (Otc), Polymer Technology Systems, Inc. (2000) Summary page 2.

## Most influential descendants
- K071507: PTS Panels Chol+HDL+Glu Panel Test Strips (2007), 2 descendants of its own
- K071593: PTS Panels Chol+HDL Panel Test Strips (2007), 1 descendant of its own
- K070017: PTS Panels Metabolic Chemistry Panel Test Strips (2007), 1 descendant of its own
- K162282: CardioChek Plus Test System, CardioChek Home Test System (2016), 0 descendants of its own
- K142302: BioScanner Plus Glucose Test System, PTS PANELS Chol+Glu Test Panel System, PTS PANELS Lipid Panel Test System, PTS PANELS HDL Cholesterol Test System, PTS PANELS CHOL+HDL Test System, PTS PANELS CHOL+HDL+GLU Panel Test System, PTS PANELS Metabolic Chemistry Panel Test System (2014), 0 descendants of its own

## Indications for use
PTS PANELS HDL Cholesterol Test Strips are intended to measure high density lipoprotein cholesterol in whole blood. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Source page: https://510kreport.com/device/K060617
Methodology: https://510kreport.com/methodology