510(k) · Cleared
ClearedThermo Scientific Mas R Doa Total
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microgenics Corporation · DIF Drug Mixture Control Materials
Cleared on Mar 24, 2011 as substantially equivalent to K971058 (Medical Analysis Systems, Inc., 1997) and 1 other predicate after a 99-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Mar 24, 2011
- Review
- 99 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K951135 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951135 | Multi-Drug Control Set | Microgenics Corp. | 1995 | — |
| −1 | K040758 | MGC Dau Control Sets: Primary, Clinical and Select | Microgenics Corp. | 2004 | — |
| 0 (this device) | K103656 | Thermo Scientific Mas R Doa Total | Microgenics Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DIF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971058 | Doa-Xse, Liquid Drugs of Abuse Control Levels 2,3, and 4 (Sdoa- 202,303,404)Summary page 1…eagent or instrument defects. Legally marketed device to which equivalency is claimed MAS® DOA Total is substantially equivalent to the previously cleared MAS DOA-XSE (K971058) and MGC DAU Control Sets: Primary, Clinical, and Select (K040758). Description af Device DOA TOTAL is prepared f… | 1997 |
| * | K040758 | MGC Dau Control Sets: Primary, Clinical and SelectSummary page 1…uivalency is claimed MAS® DOA Total is substantially equivalent to the previously cleared MAS DOA-XSE (K971058) and MGC DAU Control Sets: Primary, Clinical, and Select (K040758). Description af Device DOA TOTAL is prepared from certified drug free human urine pools. Analyte levels are adju… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 9.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DIF
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIF
35in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIF
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIF
1in 2016
MAUDE reports naming product code DIF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 3 | 35 | 0 | 3 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 5 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103656: Thermo Scientific Mas R Doa Total.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103656
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026