# K143691: LDLC3 LDL-Cholesterol Gen.3

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Operations (Rdo)
- Decided: Jan 28, 2015 after 35 days
- Product code: LBR (Ldl & Vldl Precipitation, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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 K974733 (1998). 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)
- K974733: Boehringer Mannheim Direct LDL - Cholesterol, Boehringer Mannheim Corp. (1998) Summary page 4.

## Indications for use
The LDL-Cholesterol Gen. 3 assay is an in-vitro test for the quantitative determination of LDL-cholesterol in human serum and plasma on Roche/Hitachi cobas c systems. 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/K143691
Methodology: https://510kreport.com/methodology