# K011658: Calibrator for Automated Systems (C.F.a.S.) Lipids

- Pathway: 510(k) (Abbreviated)
- Applicant: Rochdiag
- Decided: Jul 31, 2001 after 63 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
Longest line of descent: 1 generation back to K974825 (1998). 1 ancestor in all.
2 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)
- K974825: Boehringer Mannheim C.F.a.S. - HDL/LDL-C-Plus, Boehringer Mannheim Corp. (1998) Summary page 2.

## Most influential descendants
- 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 use in the calibration of Roche lipid methods on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K011658
Methodology: https://510kreport.com/methodology