# K071593: PTS Panels Chol+HDL Panel Test Strips

- Pathway: 510(k) (Special)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Oct 15, 2007 after 126 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
Longest line of descent: 2 generations back to K990247 (1999). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981493: MTM Bioscanner C Test Strips Model Number Bsa 200, Bsa 210, Bsa 220, Polymer Technology Systems, Inc. (1998) Summary page 2.
- K990688: MTM Bioscanner C Test Strips, Polymer Technology Systems, Inc. (1999) Summary page 2.
- K060617: PTS Panels HDL Cholesterol Test Strips, Polymer Technology Systems, Inc. (2006) Summary page 2.

## Most influential descendants
- K162282: CardioChek Plus Test System, CardioChek Home Test System (2016), 0 descendants of its own

## Recalls of this device
- Feb 20, 2009 · Not classified · Z-0975-2010: Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date.

## Indications for use
PTS PANELS CHOL+HDL Panel Test Strips are intended to be used by medical professionals and individuals in the home to measure cholesterol and high density lipoprotein cholesterol in whole blood. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders. 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/K071593
Methodology: https://510kreport.com/methodology