# K980667: Infinity Cholesterol Reagent (Procedure NO. 401)

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Apr 21, 1998 after 60 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.

Source page: https://510kreport.com/device/K980667
Methodology: https://510kreport.com/methodology