# K973284: Cobas Integra HDL-Cholesterol Direct

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Dec 18, 1997 after 107 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 K951595 (1995). 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)
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 3.

## Indications for use
The cassette COBAS INTEGRA HDL - Cholesterol Direct (HDL-D) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of HDL - cholesterol direct concentration in serum and plasma.

Source page: https://510kreport.com/device/K973284
Methodology: https://510kreport.com/methodology