510(k) · Cleared
ClearedUcp Rapid Drug Screening Tests
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 Apr 29, 2005 after a 58-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Apr 29, 2005
- Review
- 58 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK050540 Ucp Rapid Drug Screening TestsUcp Biosciences, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK061617 Forsure One Step Dip & Read (X) Drug Screen TestTianjin New Bay Bioresearch Co., Ltd. · 2006
Most influential descendants
Showing 1 of 1 · See all- K061617Forsure One Step Dip & Read (X) Drug Screen TestTianjin New Bay Bioresearch Co., Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050540 | Ucp Rapid Drug Screening Tests | Ucp Biosciences, Inc. | 2005 | — |
| +1 | K061617 | Forsure One Step Dip & Read (X) Drug Screen Test | Tianjin New Bay Bioresearch Co., Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 |
|---|---|---|---|
| * | — | ACON One Step Drugs of Abuse Tests Named without a submission number |
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 |
|---|---|---|---|
| K061617 | Forsure One Step Dip & Read (X) Drug Screen Test | 2006 | 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, K061617 (Tianjin New Bay Bioresearch Co., Ltd., 2006) 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.
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 RapidTM Drug Screening Test Strips and UCP RapidTM Drug Screening Test Devices are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Methamphetamine, MDMA, Opiates, Methadone, Oxycodone, Phencyclidine, Marijuana and their metabolites in human urine at the following cutoff levels: Test Calibrator Cut-off Amphetamine D-Amphetamine 1000 ng/mL Barbiturates Secobarbital 300…
Read the full statement (155 words)
The UCP RapidTM Drug Screening Test Strips and UCP RapidTM Drug Screening Test Devices are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Methamphetamine, MDMA, Opiates, Methadone, Oxycodone, Phencyclidine, Marijuana and their metabolites in human urine at the following cutoff levels:
Test Calibrator Cut-off
Amphetamine D-Amphetamine 1000 ng/mL
Barbiturates Secobarbital 300 ng/mL
Benzodiazepine Oxazepam 300 ng/mL
Cocaine Benzoylecgonine 300 ng/mL
Methamphetamine D-Methamphetamine 1000 ng/mL
Methadone Methadone 300 ng/mL
MDMA D, L-MDMA 500 ng/mL
Opiates 300 Morphine 300 ng/mL
Opiates 2000 Morphine 2000 ng/mL
Oxycodone Oxycodone 100 ng/mL
Phencyclidine Phencyclidine 25 ng/mL
Cannabinoids 11-nor-A 9-THC-9 COOH 50 ng/mL
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 summary.
https://510kreport.com/device/K050540 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050540: Ucp Rapid Drug Screening Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050540
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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