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 Jul 19, 2013 after a 30-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jul 19, 2013
- Review
- 30 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK131811 Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsUcp Biosciences, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK152908 Ucp Compact Drug TestsUcp Biosciences, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K152908Ucp Compact Drug TestsUcp Biosciences, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K131811 | Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups | Ucp Biosciences, Inc. | 2013 | — |
| +1 | K152908 | Ucp Compact Drug Tests | Ucp Biosciences, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152908 | Ucp Compact Drug Tests | 2016 | 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?
- Of its descendants, K152908 (Ucp Biosciences, Inc., 2016) has gone furthest, with 0 descendants of its own.
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 and UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: Drug — Calibrator — Cutoff Amphetamine — D-Amphetamine — 1000 ng/mL Barbiturates — Secobarbital — 300 ng/mL Benzodiazepiies — Oxazepam — 300 ng/mL Buprenorphine — Buprenarphine — 10 ng/mL Cocaine — Benzoylecgonine — 300 ng/mL Marijuana — Delta-9-THC-COOH — 50…
Read the full statement (315 words)
The UCP Compact Drug Test Cards and UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine:
Drug — Calibrator — Cutoff
Amphetamine — D-Amphetamine — 1000 ng/mL
Barbiturates — Secobarbital — 300 ng/mL
Benzodiazepiies — Oxazepam — 300 ng/mL
Buprenorphine — Buprenarphine — 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 — Morphine — 2000 ng/mL
Oxycodone — Oxycodone — 100 ng/mL
Phencyclidine — Phencyclidine — 25 ng/mL
Propoxyphene — Propoxyphene — 300 mg/mL
Tricyclic Antidepressants — 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 health care professional users.
The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressanits are ingested, even at or above therapeutic doses. There are no uniformly 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 as stated in the FDA 510(k) statement.
https://510kreport.com/device/K131811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131811: 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 6, 2026. https://510kreport.com/device/K131811
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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