510(k) · Cleared
ClearedControl Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set Amphetamine 1000 and Control Set Amphetamine 500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DIF Drug Mixture Control Materials
Cleared on Mar 25, 2008 as substantially equivalent to K070200 (Roche Diagnostics Corp., 2007) after a 60-day review. Its family tree reaches back 2 generations to 2006. 1 later device descends from it.
- Decided
- Mar 25, 2008
- Review
- 60 days
- Class
- Class I
- Product code
- DIF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K060429 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK060429 TDM Control SetRoche Diagnostics Corp. · 2006
- 1 generation backK070200 TDM Control Set, Model Cat# 04521536Roche Diagnostics Corp. · 2007
- This deviceK080183 Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control…Roche Diagnostics Corp. · 2008
- Descendant · cites it directly · 0 of its ownK090939 Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control…Roche Diagnostics · 2009
Most influential descendants
Showing 1 of 1 · See all- K090939Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical…Roche Diagnostics · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K060429 | TDM Control Set | Roche Diagnostics Corp. | 2006 | — |
| −1 | K070200 | TDM Control Set, Model Cat# 04521536 | Roche Diagnostics Corp. | 2007 | — |
| 0 (this device) | K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set… | Roche Diagnostics Corp. | 2008 | — |
| +1 | K090939 | Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat… | Roche Diagnostics | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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? (1)
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 |
|---|---|---|---|
| * | K070200 | TDM Control Set, Model Cat# 04521536Summary page 1…nical Toxicology Control Material 4) Predicate We claim substantial equivalence for each of the devices to the currently devices marketed TDM Control Set (K070200). 1 of 11 5) Device… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090939 | Roche C.F.a.S. Dat Qualitative Plus Clinical Calibrator and Control Set Dat Clinical… | 2009 | 0 |
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 2 years and passes through 1 company; a new generation was cleared every 1.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K090939 (Roche Diagnostics, 2009) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DIF devicesDIF Drug Mixture Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The Control Set DAT I is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information. The Control Set DAT II is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry…
Read the full statement (258 words)
The Control Set DAT I is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.
The Control Set DAT II is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.
The Control Set DAT III is for use as an assayed control in the Roche test system for the qualitative and semiquantitative determination of drugs of abuse in human urine on automated clinical chemistry analyzers as indicated in the System Information.
None of these above named products can be used with the Roche Abuscreen OnLine assay for Amphetamines or the COBAS INTEGRA Amphetamines cobas c pack (AMPS). The package insert or method sheet for information regarding the controls has appropriate instructions for use with these assays.
The Control Set Amphetamine 1000 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.
The Control Set Amphetamine 500 is for use as an assayed control with the Roche Abuscreen OnLine assay for Amphetamines and the COBAS INTEGRA Amphetamines cobas c pack (AMPS) for the qualitative and semiquantitative determination of amphetamines in human urine on automated clinical chemistry analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080183 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080183: Control Set Dat I, Contrl Set Dat II, Control Set Dat Iii, Control Set Amphetamine 1000 and Control Set Amphetamine 500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080183
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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