# K992132: Cholesite Test System

- Pathway: 510(k) (Traditional)
- Applicant: Gds Technology, LLC
- Decided: Aug 20, 1999 after 58 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
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. The FDA summary names no predicate by number.

## Indications for use
The GDS® CholeSite® Test System is an i vitro diagnostic product for the quantitative determination of total cholesterol in whole blood. It is intended for the sole use with the GDS® Stat-Site® Meter.

Source page: https://510kreport.com/device/K992132
Methodology: https://510kreport.com/methodology