# K012287: Modification to: Cobas Integra LDL-Cholesterol Plus 2ND Generation

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Aug 7, 2001 after 18 days
- Product code: MRR (System, Test, Low Density, Lipoprotein)
- Device class: 1
- Regulation: 21 CFR 862.1475
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K974733 (1998). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974733: Boehringer Mannheim Direct LDL - Cholesterol, Boehringer Mannheim Corp. (1998) Summary page 1.

## Most influential descendants
- K111753: Hitachi Clinical Analyzer S Test Reagent Catridge for: Cholestrol, HDL, LDL, and Triglyceride (2011), 0 descendants of its own
- K032936: Direct LDL Cholesterol Liquid Color and Stanbio Direct HDL/LDL Cholesterol Calibrator (2004), 0 descendants of its own

## Recalls of this device
- May 7, 2015 · Class II · Z-1927-2015: 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
- Jun 11, 2008 · Not classified · Z-0006-2009: Some of the labels are glossy, resulting in the bar code being difficult to read by the bar code reader.

## Indications for use
The cassette COBAS Integra LDL-Cholesterol plus 2nd Generation (HDL-C) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of LDL-Cholesterol concentration in serum and plasma. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Source page: https://510kreport.com/device/K012287
Methodology: https://510kreport.com/methodology