# K080085: Mas Tox Control

- Pathway: 510(k) (Traditional)
- Applicant: Thermo Fisher Scientific
- Decided: Apr 30, 2008 after 110 days
- Product code: DIF (Drug Mixture 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 Control is intended for use as a consistent test sample of known concentration for monitoring assay conditions in the measurement of Benzodiazepines and Barbiturates in human serum and plasma and Tricyclic Antidepressants drugs (TCA) in human serum, plasma and urine. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Source page: https://510kreport.com/device/K080085
Methodology: https://510kreport.com/methodology