# K101456: Roche Diagnostics Calibrator for Automated Systems, Roche Diagnostics Calibrator Calibrator for Automated System

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics
- Decided: Sep 8, 2010 after 105 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: 3 generations back to K990460 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062319: Calibrator for Automated Systems (C.F.a.S.), Model 10759350 360, Roche Diagnostics Corp. (2006) Summary page 1.
- K003158: Roche Diagnostics CK-MB, Roche Diagnostics Corp. (2000) Summary page 1.

## Indications for use
Calibrator for automated systems (C.fa.s) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. C.fa.s. (Calibrator for automated systems) CK-MB is for use in the calibration of Roche methods for the quantitative determination of CK-MB on Roche clinical chemistry analyzers as specified in the value sheets.

Source page: https://510kreport.com/device/K101456
Methodology: https://510kreport.com/methodology