# K040693: PTS Panels LDL Cholesterol Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Polymer Technology Systems, Inc.
- Decided: Jul 6, 2004 after 111 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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: 1 generation back to K974733 (1998). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974733: Boehringer Mannheim Direct LDL - Cholesterol, Boehringer Mannheim Corp. (1998) Summary page 1.

## Recalls of this device
- May 29, 2008 · Not classified · Z-1132-2010: The expiration date was extended by 20 weeks without justification.

## Indications for use
PTS PANELS LDL Cholesterol Test Strips are intended to measure low density lipoprotein. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. This system is intended for professional use.

Source page: https://510kreport.com/device/K040693
Methodology: https://510kreport.com/methodology