510(k) · Cleared
ClearedUcp Home Drug Screening 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 Nov 30, 2012 as substantially equivalent to K091588 (Ucp Biosciences, Inc., 2009) after a 113-day review. Its family tree reaches back 1 generation to 2009.
- Decided
- Nov 30, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K091588 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK091588 Ucp Home Drug Screening TestsUcp Biosciences, Inc. · 2009
- This deviceK122419 Ucp Home Drug Screening Test CupsUcp Biosciences, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K091588 | Ucp Home Drug Screening Tests | Ucp Biosciences, Inc. | 2009 | — |
| 0 (this device) | K122419 | Ucp Home Drug Screening Test Cups | Ucp Biosciences, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K091588 | Ucp Home Drug Screening TestsSummary page 2…91) Device Classification: II Substantially Equivalent Devices: UCP Home'r Drug Screening Test CardsJUCP Hom Drug Screening Test Cups (k091588) Product Description: UCP Home Drug Screening Test Cups are competitive binding, lateral flow immunochromatographic assays for… | 2009 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K091588.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Home Drug Screening Test Cups are rapid, qualitative, competitive binding inmmoassays 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 Cocaine Benzoylecgonine 300 ng/mL Marijuana Delta-9-THC-COOH 50 nglmL Methadone Methadone 300 ng/mL Methamphetamine D-Methamphetamine 1000 ng/mL MDMA MDMA…
Read the full statement (264 words)
The UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding inmmoassays 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
Cocaine Benzoylecgonine 300 ng/mL
Marijuana Delta-9-THC-COOH 50 nglmL
Methadone Methadone 300 ng/mL
Methamphetamine D-Methamphetamine 1000 ng/mL
MDMA MDMA 500 nglmL
Morphine Morphine 300 ng/mL
Opiates 2000 Morphine 2000 ng/mL
*Oxycodone Oxycodone 100 nglmL
Phencyclidine Phencyclidine 25 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 health care professional users.
Ttests 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 uniformly 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 (GCIMS).
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/K122419 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122419: Ucp Home Drug Screening 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/K122419
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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