# K901900: L.D.X Lipid Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Cholestech Corp.
- Decided: Jul 24, 1990 after 88 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 16, 2010 · Not classified · Z-0964-2012: Alere has identified that a bias on results for certain analytes tested on the Alere Cholestech LDX System may exist due to humidity variability.

Source page: https://510kreport.com/device/K901900
Methodology: https://510kreport.com/methodology