510(k) · Cleared
ClearedUcp Rapid Drug Screening Buprenorphine, Amp 300, Mamp 500, Coc 150 Test;
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ucp Biosciences, Inc. · DJG Enzyme Immunoassay, Opiates
Cleared on Feb 24, 2010 after a 266-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 24, 2010
- Review
- 266 days
- Class
- Class II
- Product code
- DJG
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 DJG? 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 DJG device
- #1 K232659 Dochek® Multi-Drug Urine Test Cup Rx, Dochek®…score 17.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | — | ACON BUP One Step Buprenorphine Test Strip Named without a submission number | |
| * | — | ACON BUP One Step Buprenorphine Test Device Named without a submission number | |
| * | — | ACON AMP-300 One Step Amphetamine Test Strip Named without a submission number | |
| * | — | ACON AMP-300 One Step Amphetamine Test Device Named without a submission number | |
| * | — | ACON mAMP-500 One Step Methamphetamine Test Strip Named without a submission number | |
| * | — | ACON mAMP-500 One Step Methamphetamine Test Device Named without a submission number | |
| * | — | ACON COC-150 One Step Cocaine Test Strip Named without a submission number | |
| * | — | ACON COC-150 One Step Cocaine Test Device Named without a submission number |
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.
How does its category compare?
All DJG devicesDJG Enzyme Immunoassay, Opiates: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DJG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DJG
31in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJG
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJG
1in 2025
MAUDE reports naming product code DJG, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 6 | 187 | 0 | 0 |
| 2011 | 6 | 233 | 1 | 4 |
| 2012 | 5 | 95 | 0 | 1 |
| 2013 | 5 | 60 | 0 | 4 |
| 2014 | 9 | 62 | 0 | 0 |
| 2015 | 12 | 141 | 0 | 3 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 4 | 101 | 0 | 1 |
| 2018 | 5 | 134 | 0 | 1 |
| 2019 | 3 | 235 | 1 | 0 |
| 2020 | 5 | 30 | 0 | 0 |
| 2021 | 3 | 422 | 0 | 2 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 10 | 140 | 0 | 0 |
| 2024 | 5 | 150 | 0 | 3 |
| 2025 | 3 | 31 | 2 | 1 |
| 2026 | 3 | 157 | 0 | — |
What is it indicated for?
The UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays for the detection the following drug in human urine: Test Calibrator Cut-off Buprenorphine Buprenorphine 10 ng/mL Amphetamine D-Amphetamnine 300 ng/mL Methamphetarnine D-Methamphetamine 500 ng/mL Cocaine Benzoylecgonine 150 ng/mL The tests contain three formats: 1) Test Card/Strip; 2) Test Device, 3) Test…
Read the full statement (160 words)
The UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays for the detection the following drug in human urine:
Test Calibrator Cut-off
Buprenorphine Buprenorphine 10 ng/mL
Amphetamine D-Amphetamnine 300 ng/mL
Methamphetarnine D-Methamphetamine 500 ng/mL
Cocaine Benzoylecgonine 150 ng/mL
The tests contain three formats: 1) Test Card/Strip; 2) Test Device, 3) Test Cup. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use.
The tests only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K091612: Ucp Rapid Drug Screening Buprenorphine, Amp 300, Mamp 500, Coc 150 Test;.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K091612
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026