510(k) · Cleared
ClearedUcp Multiple Drug Screen Test Cups
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ucp Biosciences, Inc. · LFG Radioimmunoassay, Tricyclic Antidepressant Drugs
Cleared on Sep 20, 2007 after a 55-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 20, 2007
- Review
- 55 days
- Class
- Class II
- Product code
- LFG
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 LFG? 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All LFG devicesLFG Radioimmunoassay, Tricyclic Antidepressant Drugs: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · LFG
1in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · LFG
Too few LFG 510(k)s in any year since 2007 to give a median.
Recalls per year · LFG
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFG
1in 2024
MAUDE reports naming product code LFG, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels: Test Calibrator Cut-off Amphetamine D-Amphetandne 1000 ng/mL Barbiturates Secobarbital…
Read the full statement (170 words)
The UCP Multiple Drug Screen Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturates, Bezodiazepines, Cocaine, Marijuana, Methadone, Methamphetamine, MDMA, Morphine, Opiate 2000, Oxycodone, Phencyclidine, Tricyclic Antidepressants, Propoxyphene and their metabolites in human urine at the following cutoff levels:
Test Calibrator Cut-off
Amphetamine D-Amphetandne 1000 ng/mL
Barbiturates Secobarbital 300 ng/mL
Benzodiazepines Oxazepam 300 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
Opiate 2000 Morphine 2000 ng/mL,
Oxycodone Oxycodone 100 ng/mL
Phencyclidine Phencylidine 25 ng/mL
Tricyclic Antidepressant Nortriptyline 1000 ng/mL
Propoxyphene Propoxyphene 300 ng/mL
The tests provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). The test configuration comes with any combination of multiple drug screen tests. 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/K072062 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072062: Ucp Multiple Drug Screen Test Cups.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072062
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026