# K013373: Omni C Analyzer

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Nov 2, 2001 after 22 days
- Product code: CEM (Electrode, Ion Specific, Potassium)
- Device class: 2
- Regulation: 21 CFR 862.1600
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K940918 (1994). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990092: Avl Omni Modular Analyzer, Avl Scientific Corp. (1999) Summary page 2.

## Most influential descendants
- K032311: Roche Diagnostics Omni S Analyzer (2003), 1 descendant of its own
- K111188: Cobas B 123 Poc System, Cobas B 123 Autoqc Pack Tri-Level, Cobas B 123 Autocvc Pack, Roche Combitrol Plus B (2012), 0 descendants of its own

## Recalls of this device
- Dec 16, 2002 · Not classified · Z-0438-03: Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.

## Indications for use
The Roche Diagnostics Omni C Analyzer is intended to be used for the measurement of pH, P02, PCO2, sodium, potassium, ionized calcium, chloride, hematocrit, total hemoglobin and oxygen saturation in samples of whole blood, serum, plasma and aqueous solutions as appropriate.

Source page: https://510kreport.com/device/K013373
Methodology: https://510kreport.com/methodology