# K963213: Boehringer Mannheim Direct HDL-Cholesterol

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Oct 23, 1996 after 68 days
- Product code: LBS (Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, 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.
4 later devices descend from it; 3 cite it directly.
0 of 5 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) Boehringer Mannheim HDL Cholesterol: named in the summary without a submission number

## Most influential descendants
- K012286: Modification to:Cobas Integra HDL-Cholesterol Plus 2ND Generation (2001), 1 descendant of its own
- K181373: Extended Lipid Panel Assay (2018), 0 descendants of its own
- K982767: Raichem HDL-Cholesterol Direct Reagent, HDL-Cholesterol Calibrator (1998), 0 descendants of its own
- K981580: HDL (1998), 0 descendants of its own

## Recalls of this device
- May 7, 2015 · Class II · Z-1924-2015: 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
Boehringer Mannheim Direct HDL is intended for the quantitative determination of high-density lipoprotein Cholesterol (HDL-C) in serum and plasma.

Source page: https://510kreport.com/device/K963213
Methodology: https://510kreport.com/methodology