# K923504: Cholesterol Enzymatic Endpoint

- Pathway: 510(k) (Traditional)
- Applicant: Randox Laboratories, Ltd.
- Decided: Jan 10, 1994 after 544 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K150654: Cholesterol (2015), 0 descendants of its own

## Recalls of this device
- Jun 22, 2022 · Class II · Z-1424-2022: Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generat
- Nov 1, 2021 · Class II · Z-0328-2022: When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range
- Mar 17, 2016 · Class II · Z-1652-2016: Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depre

Source page: https://510kreport.com/device/K923504
Methodology: https://510kreport.com/methodology