# K990460: Calibrator for Automated Systems (C.F.a.S.)

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 22, 1999 after 38 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.
43 later devices descend from it; 5 cite it directly.
0 of 44 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) Roche Serum Calibrator: named in the summary without a submission number

## Most influential descendants
- K033501: Modification to Calibrator for Automatic Systems (Cfas) (2003), 31 descendants of its own
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) (2005), 15 descendants of its own
- K030169: Setpoint Chemistry Calibrator (2003), 4 descendants of its own
- K081731: Dimension Cki Flex Reagent Cartridge, Dimension Mbi Flex Reagent Cartridge, and Cki/Mbi Calibrator, Models DF38, DF32 (2008), 3 descendants of its own
- K060854: Abx Pentra 400:  Lipoproteins (2006), 3 descendants of its own

## Indications for use
For use as a calibrator of clinical chemistry assays. Biological materials are added as required to obtain desired component levels. This calibrator material is well suited for automated analytical procedures. Levels of constituent analytes are provided in product labeling.

Source page: https://510kreport.com/device/K990460
Methodology: https://510kreport.com/methodology