# K133330: C.F.a.S. Proteins, C.F.a.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein & Precipath Protein

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Nov 26, 2013 after 25 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: 4 generations back to K811832 (1981). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080607: Calibrator for Automated Systems (C.F.a.S.) Proteins with Model 11355279160, Roche Diagnostics Corp. (2008) Summary page 2.
- K040245: Calibrator for Automated Systems Prealbumin-Aslo-Ceruloplasmin (C.F.a.S. Pac), Roche Diagnostics Corp. (2004) Summary page 2.
- K102016: Precicontrol Clinchem Multi 1 and 2, Roche Diagnostics (2010) Summary page 2.
- K981401: Boehringer Mannheim Precinorm Precipath Protein Controls, Boehringer Mannheim Corp. (1998) Summary page 2.

## Indications for use
C.f.a.s. (Calibrator for automated systems) PAC (Prealbumin-ASLQ-Ceruioplasmin) is for usC inl the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the valuc sheets. C.f.a.s. (Calibrator for automated systems) Proteins is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. PreciControl ClinChem Multi I s for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in thle value sheets. PreciControl ClinChemn Multi 2 is for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets. Precinorm Protein and Precipath Protein are for the use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

Source page: https://510kreport.com/device/K133330
Methodology: https://510kreport.com/methodology