# K031392: Mas Tox Ammonia Controlliquid Assayed Tox Ammonia Control

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Jul 1, 2003 after 60 days
- Product code: DKC (Alcohol Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
MAS@Tox Ammonia Control is intended for use in the clinical laboratory as quantitative controls for monitoring test procedures used to assay human serum and/or plasma specimens for alcohol, ammonia, acetaminophen and salicylate. Include Tox Ammonia Control with patient serum or plasma specimens when assaying for any of the listed constituents. Assay values are provided for specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. Bayer ToxAmmonia For in vitro diagnostic use to monitor the precision and the accuracy of chemistry systems, including the ADVIA IMS@

Source page: https://510kreport.com/device/K031392
Methodology: https://510kreport.com/methodology