# K031683: Tox Ammonia Calibrator

- Pathway: 510(k) (Abbreviated)
- Applicant: Bayer Healthcare, LLC
- Decided: Aug 6, 2003 after 68 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K990460 (1999). 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)
- K030169: Setpoint Chemistry Calibrator, Bayer Healthcare, LLC (2003)

## Recalls of this device
- Apr 5, 2023 · Class II · Z-1631-2023: Reassignment of the Atellica CH Toxicology Calibrators (TOX CAL) and ADVIA Chemistry ToxAmmonia Calibrators for the Atellica CH Salicylate (Sal) Assay due to a positive bias

## Indications for use
Bayer ToxAmmonia Calibrator is intended for in vitro diagnostic use to calibrate Acetaminophen, Ammonia, Ethanol and Salicylate assays on the ADVIA IMS Chemistry systems.

Source page: https://510kreport.com/device/K031683
Methodology: https://510kreport.com/methodology