510(k) · Cleared
ClearedMP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mp Biomedicals, LLC · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Jun 2, 2017 as substantially equivalent to K003809 (Rapid Diagnostics, Inc., 2001) and 2 other predicates after a 280-day review. Its family tree reaches back 2 generations to 2004.
- Decided
- Jun 2, 2017
- Review
- 280 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K033566 (2004). 3 ancestors in all, the oldest K003809 (2001). No later device cites it as a predicate yet.
- Root · 2 generations backK033566 Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062Rapid Diagnostics, Inc. · 2004
- 1 generation backK051958 MP Rapidoxy Test Strip, Model 07RD-7073Mp Biomedicals, LLC · 2006
- This deviceK162395 MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupMp Biomedicals, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033566 | Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062 | Rapid Diagnostics, Inc. | 2004 | — |
| −1 | K051958 | MP Rapidoxy Test Strip, Model 07RD-7073 | Mp Biomedicals, LLC | 2006 | — |
| 0 (this device) | K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup | Mp Biomedicals, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 DIO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K003809 | Rapid Drugs of Abuse Single and Multiple Test PanelsSummary page 6…is positive. 9. Predicate Devices The following 510(k) cleared devices belong to Rapid Diagnostics; Rapid Drugs of Abuse Single and Multiple Test Panels (K003809), MICROMEDIC Drugs of Abuse Panel Test (K033566) and RapidBUP Test Strip / RapidOXY Test Strip (K051958). These previously cleare… | 2001 |
| * | K033566 | Micromedic Drugs of Abuse Panel Test (9), Catalog Number 07RD-7062Summary page 6…s The following 510(k) cleared devices belong to Rapid Diagnostics; Rapid Drugs of Abuse Single and Multiple Test Panels (K003809), MICROMEDIC Drugs of Abuse Panel Test (K033566) and RapidBUP Test Strip / RapidOXY Test Strip (K051958). These previously cleared drugs of abuse test strip and drugs of abuse t… | 2004 |
| * | K051958 | MP Rapidoxy Test Strip, Model 07RD-7073Summary page 6…iagnostics; Rapid Drugs of Abuse Single and Multiple Test Panels (K003809), MICROMEDIC Drugs of Abuse Panel Test (K033566) and RapidBUP Test Strip / RapidOXY Test Strip (K051958). These previously cleared drugs of abuse test strip and drugs of abuse test panels are predicate devices to the MP DOA-10 Panel… | 2006 |
| † | K030211 | Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016 | 2003 |
| † | K023252 | Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020 | 2002 |
| † | K020716 | Rapid Opiates Test Strip II, Rapid Opiates Test Card II and Doa Multiple Drug Test Cards… | 2002 |
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 13 years and passes through 2 companies; a new generation was cleared every 10.9 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml.; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml…
Read the full statement (174 words)
The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup are immunochromatographic one-step in-vitro tests intended for the qualitative detection of up to ten or eleven different drug substances, respectively, in human urine at the following cut-off levels: amphetamine, 1000 ng/ml; barbiturate, 300 ng/ml; benzodiazepine, 300 ng/ml; buprenorphine, 10 ng/ml; cannabinoid, 50 ng/ml.; cocaine, 300 ng/ml; methadone, 300 ng/ml; methamphetamine, 1000 ng/ml; opiates, 300/2000 ng/ml; oxycodone, 100 ng/ml and phencyclidine, 25 ng/ml. Only one cutoff concentration will be included per analyte per device.
The MP DOA-10 Panel Test Cup and the MP DOA-11 Panel Test Cup may be used in a point-of-care (POC) setting and will provide preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) has been established as the preferred confirmatory method by the Substance Abuse Mental Health Services Administration (SAMSHA). Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162395: MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162395
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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