# K033501: Modification to Calibrator for Automatic Systems (Cfas)

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 20, 2003 after 15 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 K990460 (1999). 1 ancestor in all.
31 later devices descend from it; 17 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990460: Calibrator for Automated Systems (C.F.a.S.), Roche Diagnostics Corp. (1999) Summary page 2.

## Most influential descendants
- K052007: Abx Pentra 400 Clinical Chemistry Analyzer (Option: I.S.E. Module) (2005), 15 descendants of its own
- K060854: Abx Pentra 400:  Lipoproteins (2006), 3 descendants of its own
- K123171: Abx Pentra Calcium as CP, Abx Pentra Urine Control L/H, Abx Pentra Multical, Abx Pentra N Control, and Abx Pentra P Cont (2013), 2 descendants of its own
- K122083: Elitech Clinical Systems CK Nac SL (2012), 1 descendant of its own
- K110530: Abx Pentra Creatinine 120 CP; Abx Pentra Multical;  Abx Pentra N Control; Abx Pentra P Control; Abx Pentra Urine Control (2012), 1 descendant of its own

## Indications for use
Calibrator for automated systems (C.f.a.s.) is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet.

Source page: https://510kreport.com/device/K033501
Methodology: https://510kreport.com/methodology