# K031880: Ammonia/Ethanol/CO2 Calibrator, Control Normal, Control Abnormal

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Jul 16, 2003 after 28 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951595 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952282: Roche Ammonia/Ethanol/CO2 Calibrator, Roche Diagnostic Systems, Inc. (1995) Summary page 2.
- K951595: Roche Cobas Integra Analyzer, Reagent Cassettes, Roche Diagnostic Systems, Inc. (1995) Summary page 2.

## Recalls of this device
- Nov 14, 2007 · Not classified · Z-0377-2008: High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.
- Nov 14, 2007 · Not classified · Z-0378-2008: High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.
- Nov 14, 2007 · Not classified · Z-0379-2008: High Quality Control Recovery: Undetected high quality control recovery in bicarbonate assay.

## Indications for use
Ammonia/Ethanol/CO2 Calibrator is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the enclosed value sheet. Ammonia/Ethanol/CO2 Control is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the enclosed value sheet.

Source page: https://510kreport.com/device/K031880
Methodology: https://510kreport.com/methodology