510(k) · Cleared
ClearedUcp Drug Screening Test Cups
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ucp Biosciences, Inc. · DIS Enzyme Immunoassay, Barbiturate
Cleared on Apr 20, 2011 after a 56-day review. The FDA summary names no predicate by number. 9 later devices descend from it.
- Decided
- Apr 20, 2011
- Review
- 56 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 1 citing it directly.
- This deviceK110515 Ucp Drug Screening Test CupsUcp Biosciences, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK130463 Ucp Home Drug Screening Test; Cards, CupsUcp Biosciences, Inc. · 2013
- Descendant · 2 generations on · 6 of its ownK132812 Ucp Multi-Drug Test Key CupsUcp Biosciences, Inc. · 2014
- Descendant · 3 generations on · 3 of its ownK150791 Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen…Healgen Scientific,, LLC · 2015
- Descendant · 3 generations on · 1 of its ownK142609 CR3 Keyless Split Sample Cup Nortriptyline-BuprenorphineGuangzhou Wondfo Biotech Co., Ltd. · 2014
- Descendant · 4 generations on · 0 of its ownK163704 Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip…Healgen Scientific,, LLC · 2017
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K130463Ucp Home Drug Screening Test; Cards, CupsUcp Biosciences, Inc. · 2013 · cites it directly8descendants
- K132812Ucp Multi-Drug Test Key CupsUcp Biosciences, Inc. · 2014 · 2 generations on6descendants
- K150791Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…Healgen Scientific,, LLC · 2015 · 3 generations on3descendants
- K142609CR3 Keyless Split Sample Cup Nortriptyline-BuprenorphineGuangzhou Wondfo Biotech Co., Ltd. · 2014 · 3 generations on1descendant
- K163704Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardHealgen Scientific,, LLC · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K110515 | Ucp Drug Screening Test Cups | Ucp Biosciences, Inc. | 2011 | — |
| +1 | K130463 | Ucp Home Drug Screening Test; Cards, Cups | Ucp Biosciences, Inc. | 2013 | — |
| +2 | K132812 | Ucp Multi-Drug Test Key Cups | Ucp Biosciences, Inc. | 2014 | — |
| +3 | K150791 | Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen… | Healgen Scientific,, LLC | 2015 | — |
| +3 | K142609 | CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine | Guangzhou Wondfo Biotech Co., Ltd. | 2014 | — |
| +4 | K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card | Healgen Scientific,, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 4 | 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 DIS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K130463 | Ucp Home Drug Screening Test; Cards, Cups | 2013 | 8 |
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, K130463 (Ucp Biosciences, Inc., 2013) has gone furthest, with 8 descendants of its own.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, 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 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays 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 nglniL Cocaine Benzoylecgonine 300 ng/mL Marijuana Delta-9-THC-COOH 50 nglmL Methadone Methadone 300 nglmt Methamphetamine 0-Methamphetamine 1000 nglmL MOMA MDMA 500…
Read the full statement (298 words)
The UCP Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays 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 nglniL
Cocaine Benzoylecgonine 300 ng/mL
Marijuana Delta-9-THC-COOH 50 nglmL
Methadone Methadone 300 nglmt
Methamphetamine 0-Methamphetamine 1000 nglmL
MOMA MDMA 500 ng/rnL
Morphine Morphine 300 ng/mL
Opiate 2000 Morphine 2000 ng/mL
Oxycodone Oxycodone 100 ng/niL
Phencyclidine Phencylidine 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, including but not limited to concerned parents, 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 uniformly recognized drug levels for Barbiturate, Benzodiazepines, Oxycodone, Tricyclic Antidepressant in urine. The tests~only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for Tni-cyclic Antidepressants). Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are niot intended to be used in monitoring drug levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110515: Ucp 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/K110515
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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