510(k) · Cleared
ClearedUCP Drug Test Mini Cups
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ucp Biosciences, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Aug 21, 2015 as substantially equivalent to K130463 (Ucp Biosciences, Inc., 2013) after a 107-day review. Its family tree reaches back 2 generations to 2009.
- Decided
- Aug 21, 2015
- Review
- 107 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K091588 (2009). 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 | K091588 | Ucp Home Drug Screening Tests | Ucp Biosciences, Inc. | 2009 | — |
| −1 | K130463 | Ucp Home Drug Screening Test; Cards, Cups | Ucp Biosciences, Inc. | 2013 | — |
| 0 (this device) | K151213 | UCP Drug Test Mini Cups | Ucp Biosciences, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 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? (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 |
|---|---|---|---|
| * | K130463 | Ucp Home Drug Screening Test; Cards, CupsSummary page 8…usion: Based on the test principle and acceptable performance characteristics, it is concluded that the candidate device is substantially equivalent to the predicate in k130463. | 2013 |
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 6 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K130463.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UCP Drug Test Mini Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine: Test Calibrator Cut-off Amphetamine D-Amphetamine 1000 ng/mL Barbiturates Secobarbital 300 ng/mL Benzodiazepines Oxazepam 300 ng/mL Buprenorphine Buprenorphine 10 ng/mL Cocaine Benzoylecgonine 300 ng/mL Marijuana Delta-9-THC-COOH 50 ng/mL Methadone Methadone 300 ng/mL Methamphetamine…
Read the full statement (273 words)
The UCP Drug Test Mini Cups are rapid, qualitative, competitive binding immunoassays for the detection the following drugs and their metabolites in human urine:
Test Calibrator Cut-off
Amphetamine D-Amphetamine 1000 ng/mL
Barbiturates Secobarbital 300 ng/mL
Benzodiazepines Oxazepam 300 ng/mL
Buprenorphine Buprenorphine 10 ng/mL
Cocaine Benzoylecgonine 300 ng/mL
Marijuana Delta-9-THC-COOH 50 ng/mL
Methadone Methadone 300 ng/mL
Methamphetamine D-Methamphetamine 1000 ng/mL
MDMA MDMA 500 ng/mL
Morphine Morphine 300 ng/mL
Opiates 2000 2000 ng/mL
Oxycodone Oxycodone 100 ng/mL
Phencyclidine Phencyclidine 25 ng/mL
Propoxyphene Propoxyphene 300 ng/mL
Tricyclic Antidepressant Nortiptyline 1000 ng/mL
The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for over-the-counter (OTC) users as the first step in a two step process to provide consumers, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing — the second step in the process, along with the materials for shipping the urine specimen to the laboratory, is provided. The test is also intended for prescription use
The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformiy recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressant in urine. The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring drug levels.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151213: UCP Drug Test Mini Cups.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151213
Report an extraction error
Are you the manufacturer?
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