# K103656: Thermo Scientific Mas R Doa Total

- Pathway: 510(k) (Traditional)
- Applicant: Microgenics Corporation
- Decided: Mar 24, 2011 after 99 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
Longest line of descent: 2 generations back to K951135 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971058: Doa-Xse, Liquid Drugs of Abuse Control Levels 2,3, and 4 (Sdoa- 202,303,404), Medical Analysis Systems, Inc. (1997) Summary page 1.
- K040758: MGC Dau Control Sets: Primary, Clinical and Select, Microgenics Corp. (2004) Summary page 1.

## Indications for use
MAS DOA Total is intended for use as an assayed control for monitoring assay conditions in semi-quantitative and qualitative analysis of patient urine specimens for drugs and drug metabolites. These controls are human urine based and are composed of d-methamphetamine, secobarbital, nitrazepam, oxazepam, buprenorphine, benzoylecgonine, cotinine, ethyl glucuronide, ethanol, LSD, methadone, EDDP, methaqualone, morphine, oxycodone, phencyclidine, propoxyphene, nortriptyline, and L-A-9-THC-COOH. MAS® DOA Total provides an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects.

Source page: https://510kreport.com/device/K103656
Methodology: https://510kreport.com/methodology