510(k) · Cleared
ClearedUcp Compact Drug Test Cards, Ucp Compact Drug Test 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 Jan 9, 2013 after a 26-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jan 9, 2013
- Review
- 26 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 Compact Drug Test Cards, UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: Test — Calibrator — Cut-off Amphetamine — D-Arnphetamine — 1000 ng/mL Barbiturates — Secobarbital — 300 ng/mL Benzodiazepines — Oxazepam — 300 ng/mL Cocaine — Benzoylecgonine — 300 nglmL Marijuana — Delta-9-THC-COOH — 50 nglmL Methadone — Methadone — 1300 nglmL…
Read the full statement (298 words)
The UCP Compact Drug Test Cards, UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine:
Test — Calibrator — Cut-off
Amphetamine — D-Arnphetamine — 1000 ng/mL
Barbiturates — Secobarbital — 300 ng/mL
Benzodiazepines — Oxazepam — 300 ng/mL
Cocaine — Benzoylecgonine — 300 nglmL
Marijuana — Delta-9-THC-COOH — 50 nglmL
Methadone — Methadone — 1300 nglmL
Methamphetamine — D-Methamphetamine — 1000 ng/mL
MDMA — MDMA — 500 ng/mL
Morphine — Morphine — 300 nglmL
Opiate 2000 — Morphine — 2000 nglmL
Oxycodone — Oxycodone — 100 nglmL
Phencyclidine — Phencyclidine — 25 ng/mL
Tricyclic Antidepressant — Nortriptyline — 1000 nglmL
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 health care professional users.
The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no unifornly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, 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 as stated in the FDA 510(k) statement.
https://510kreport.com/device/K123863 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123863: Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123863
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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