# K974825: Boehringer Mannheim C.F.a.S. - HDL/LDL-C-Plus

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 30, 1998 after 37 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Equal Diagnostics LDL Direct Liquid Select™ Cholesterol Calibrator: named in the summary without a submission number
- (no number) Equal Diagnostics HDL Direct Liquid Select™ Cholesterol Calibrator: named in the summary without a submission number

## Most influential descendants
- K011658: Calibrator for Automated Systems (C.F.a.S.) Lipids (2001), 2 descendants of its own
- K040245: Calibrator for Automated Systems Prealbumin-Aslo-Ceruloplasmin (C.F.a.S. Pac) (2004), 1 descendant of its own
- K133330: C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein (2013), 0 descendants of its own

## Indications for use
For the calibration of test systems for the measurement of HDL and LDL Cholesterol in human serum or plasma.

Source page: https://510kreport.com/device/K974825
Methodology: https://510kreport.com/methodology