# K031824: Cobas Integra Cholesterol Gen. 2

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 9, 2003 after 26 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K952127 (1995). 1 ancestor in all.
4 later devices descend from it; 4 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952127: Boehringer Mannheim Cholesterol Assay, Boehringer Mannheim Corp. (1995) Summary page 1.

## Most influential descendants
- K181373: Extended Lipid Panel Assay (2018), 0 descendants of its own
- K132031: Afinion Lipid Panel and Afinion Lipid Panel Control (2014), 0 descendants of its own
- K130200: Piccolo Total Cholesterol - Capillary Test System (2013), 0 descendants of its own
- K111753: Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride (2011), 0 descendants of its own

## Recalls of this device
- May 7, 2015 · Class II · Z-1921-2015: Possible drug interference when using the Trinder reaction method on multiple Cobas Analyzers. Results of Trinder tests may be falsely decreased when the tests are run with urine samples (Creatinine p

## Indications for use
The cassette COBAS Integra Cholesterol Gen2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of total cholesterol in serum and plasma Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in blood and lipid and lipoprotein metabolism disorders,

Source page: https://510kreport.com/device/K031824
Methodology: https://510kreport.com/methodology