# K992803: Sigma Diagnostics Infinity Cholesterol Reagent, Models 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Sep 13, 1999 after 25 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K962890 (1996). 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)
- K962890: Cholesterol-Incorporating  Dynamic Stab Tech (DST), Trace Scientific, Ltd. (1996) Summary page 1.

## Indications for use
Sigma Diagnostics INFINITY™ Cholesterol Reagent is intended for the in vitro quantitative, diagnostic determination of cholesterol in human serum or plasma. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Source page: https://510kreport.com/device/K992803
Methodology: https://510kreport.com/methodology