# K023558: PTS Panels Lipid Panel Test Strips

- Pathway: 510(k) (Special)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Nov 15, 2002 after 23 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990688 (1999). 3 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990688: MTM Bioscanner C Test Strips, 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.
- K000586: Bioscanner Triglycerides Test Strips, Polymer Technology Systems, Inc. (2000)

## Most influential descendants
- K090405: Lipidpro System (2009), 1 descendant of its own
- K160282: SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT Professional System, SD LipidoCare BT Home System (2017), 0 descendants of its own
- K151545: CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System, CardioChek PA Home Test System (2016), 0 descendants of its own
- K130295: Lipidpro Lipid Profile and Glucose Measuring System, Lipidpro Professional Lipid Profile and Glucose Measuring System. (2013), 0 descendants of its own
- K050182: Q.Steps Biometer G/C Dual Monitoring System (2005), 0 descendants of its own

## Recalls of this device
- Jan 16, 2019 · Class II · Z-1372-2019: Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel tes
- 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 test strips are intended to be used by healthcare professionals and individuals at home to measure three blood analytes: cholesterol, HDL cholesterol and triglycerides. 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 di.orders.

Source page: https://510kreport.com/device/K023558
Methodology: https://510kreport.com/methodology