# K952127: Boehringer Mannheim Cholesterol Assay

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jul 20, 1995 after 73 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
No predicates in its family tree.
5 later devices descend from it; 1 cites 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K031824: Cobas Integra Cholesterol Gen. 2 (2003), 4 descendants of its own
- 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-1920-2015: 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

Source page: https://510kreport.com/device/K952127
Methodology: https://510kreport.com/methodology