# K072062: Ucp Multiple Drug Screen Test Cups

- Pathway: 510(k) (Special)
- Applicant: Ucp Biosciences, Inc.
- Decided: Sep 20, 2007 after 55 days
- Product code: LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs)
- Device class: 2
- Regulation: 21 CFR 862.3910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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.

Source page: https://510kreport.com/device/K072062
Methodology: https://510kreport.com/methodology