510(k) · Cleared
ClearedUcp Multi-Drug Test Key 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 Mar 6, 2014 as substantially equivalent to K130463 (Ucp Biosciences, Inc., 2013) after a 178-day review. Its family tree reaches back 2 generations to 2009. 6 later devices descend from it.
- Decided
- Mar 6, 2014
- Review
- 178 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. 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK091588 Ucp Home Drug Screening TestsUcp Biosciences, Inc. · 2009
- 1 generation backK130463 Ucp Home Drug Screening Test; Cards, CupsUcp Biosciences, Inc. · 2013
- This deviceK132812 Ucp Multi-Drug Test Key CupsUcp Biosciences, Inc. · 2014
- Descendant · cites it directly · 3 of its ownK150791 Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen…Healgen Scientific,, LLC · 2015
- Descendant · cites it directly · 1 of its ownK142609 CR3 Keyless Split Sample Cup Nortriptyline-BuprenorphineGuangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK163704 Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip…Healgen Scientific,, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK153597 Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip…Healgen Scientific,, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK151642 Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip…Healgen Scientific,, LLC · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K150791Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…Healgen Scientific,, LLC · 2015 · cites it directly3descendants
- K142609CR3 Keyless Split Sample Cup Nortriptyline-BuprenorphineGuangzhou Wondfo Biotech Co., Ltd. · 2014 · cites it directly1descendant
- K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC · 2017 · 2 generations on0descendants
- K153597Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC · 2016 · 2 generations on0descendants
- K151642Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC · 2015 · 2 generations on0descendants
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) | K132812 | Ucp Multi-Drug Test Key Cups | Ucp Biosciences, Inc. | 2014 | — |
| +1 | K150791 | Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen… | Healgen Scientific,, LLC | 2015 | — |
| +1 | K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +2 | K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2017 | — |
| +2 | K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2016 | — |
| +2 | K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 2…Enzyme immunoassay, Phencyclidine Panel: Toxicology (9 1) Device Classification: I1 Substantially Equivalent Devices: UCP HomeTNi Drug Screening Test Cups (k130463) Product Description: UCP Multi-Drug Test Key Cups are competitive binding, lateral flow immunochromatographic assays for qual… | 2013 |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 5 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.
- Of its descendants, K150791 (Healgen Scientific,, LLC, 2015) has gone furthest, with 3 descendants of its own.
- 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. 2014, 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 Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs in human urine: Test Calibrated to Cut-off Amphetamine D-Aniphetamine 1000 ng/mL Barbiturates Secobarbital 300 nglmL Benzodiazepines Oxazepam 300 nglmL Buprenorphine Buparenorphine 10 nglmL Cocaine Benzoylecgonine 300 nglmL Marijuana Delta-9-TI4C-COQH 50 ng/mL Methadone Methadone 300 ng/mL Methainphetamine D*Methamphelamine 1000 nglmL MDMA MDMA 500 nglmL…
Read the full statement (216 words)
The UCP Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs in human urine:
Test Calibrated to Cut-off
Amphetamine D-Aniphetamine 1000 ng/mL
Barbiturates Secobarbital 300 nglmL
Benzodiazepines Oxazepam 300 nglmL
Buprenorphine Buparenorphine 10 nglmL
Cocaine Benzoylecgonine 300 nglmL
Marijuana Delta-9-TI4C-COQH 50 ng/mL
Methadone Methadone 300 ng/mL
Methainphetamine D*Methamphelamine 1000 nglmL
MDMA MDMA 500 nglmL
Morphine Morphine 300 nglmL
Opiates 2000 Morphine 2000 og/niL
Oxycodone Oxycodlonc 100 nglmL
Phencyclidine Phencyclidine 25 ng/mL
Propoxyphene Propoxyphene 300 ng/mL
Tricyclic Antidepressant Nortriptyline 1000 nglmL
The test configuration comes with a 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 in a urine sample. The second step is to send preliminary positive samples for confirmation testing by GCMS.
The test is not intended to distinguish between prescription use or abuse of the following drugs: Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants.
There are no uniformly recognized cutoff concentration levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodlone, Propxyphene, Tricyclic Antidepressant in urine.
Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132812 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132812: Ucp Multi-Drug Test Key Cups.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132812
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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