# K974733: Boehringer Mannheim Direct LDL - Cholesterol

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 26, 1998 after 39 days
- Product code: LBR (Ldl & Vldl Precipitation, Hdl)
- Device class: 1
- Regulation: 21 CFR 862.1475
- 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; 3 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)
- None. The FDA summary names its predicate without a number.
- (no number) Equal Diagnostics LDL Direct Liquid Select™ Cholesterol Test: named in the summary without a submission number

## Most influential descendants
- K012287: Modification to: Cobas Integra LDL-Cholesterol Plus 2ND Generation (2001), 2 descendants of its own
- K143691: LDLC3 LDL-Cholesterol Gen.3 (2015), 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
- K040693: PTS Panels LDL Cholesterol Test Strips (2004), 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-1928-2015: 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
For the direct, quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma.

Source page: https://510kreport.com/device/K974733
Methodology: https://510kreport.com/methodology