# K022898: PTS Panels Lipid Panel Test Strips

- Pathway: 510(k) (Special)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Sep 24, 2002 after 21 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: 3 generations back to K870012 (1987). 6 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013173: Bioscanner Plus; Lipid Panel Test Strips, Polymer Technology Systems, Inc. (2001)

## Most influential descendants
- K140068: Cardiochek Plus Test System, Cardiochek Home Test System (2015), 6 descendants of its own
- K163406: Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System (2017), 1 descendant of its own
- K201037: FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System (2022), 0 descendants of its own
- K193406: CardioChek Plus Test System; CardioChek Plus Home Test System (2022), 0 descendants of its own
- K182781: PTS Professional Chemistry Kit (2018), 0 descendants of its own

## Recalls of this device
- Jun 5, 2009 · Not classified · Z-1136-2010: Exhibits under-recovery of all analytes.

## Indications for use
The Lipid Panel Test Strips are intended to measure cholesterol, HDL cholesterol and triglycerides in whole blood on a BioScanner Plus (CardioChek brand) analyzer. The BioScanner Plus (CardioChek brand) analyzer is intended to be used by healthcare professionals to measure blood analytes on a test strip. 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. Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Source page: https://510kreport.com/device/K022898
Methodology: https://510kreport.com/methodology