# K152908: Ucp Compact Drug Tests

- Pathway: 510(k) (Traditional)
- Applicant: Ucp Biosciences, Inc.
- Decided: May 3, 2016 after 215 days
- Product code: DKZ (Enzyme Immunoassay, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K945610 (1995). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131811: Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups, Ucp Biosciences, Inc. (2013) Summary page 6.
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup, Advin Biotech (2013) Summary page 6.

## Indications for use
UCP Compact Drug Tests Cards and UCP Compact Drug Tests Cups are rapid, qualitative, competitive binding immunoassays for qualitatively the detection of the following drugs and their metabolites in human urine at the following cut-off concentrations: Test Calibrator Cut-off Marijuana: Delta-9-THC-COOH 50 ng/mL Cocaine: Benzoylecgonine 300 ng/mL Amphetamine: D-Amphetamine 1000 ng/mL Methamphetamine: D-Methamphetamine 1000 ng/mL Opiates: Morphine 2000 ng/mL Morphine: Morphine 300 ng/mL Phencyclidine: Phencyclidine 25 ng/mL Barbiturates: Secobarbital 300 ng/mL Benzodiazepines: Oxazepam 300 ng/mL Buprenorphine Buprenorphine 10 ng/mL Methadone: Methadone 300 ng/mL EDDP: EDDP 300 ng/mL Oxycodone: Oxycodone 100 ng/mL MDMA: MDMA 500 ng/mL Propoxyphene Propoxyphene 300 ng/mL Tricyclic Antidepressants: Nortriptyline 1000 ng/mL The tests are intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide the consumers with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory test in the second step of the two-step process, is provided in the package labeling. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.

Source page: https://510kreport.com/device/K152908
Methodology: https://510kreport.com/methodology