# K050540: Ucp Rapid Drug Screening Tests

- Pathway: 510(k) (Traditional)
- Applicant: Ucp Biosciences, Inc.
- Decided: Apr 29, 2005 after 58 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACON One Step Drugs of Abuse Tests: named in the summary without a submission number

## Most influential descendants
- K061617: Forsure One Step Dip & Read (X) Drug Screen Test (2006), 0 descendants of its own

## Indications for use
The UCP RapidTM Drug Screening Test Strips and UCP RapidTM Drug Screening Test Devices are rapid, qualitative, competitive binding immunoassays for the detection of Amphetamine, Barbiturate, Benzodiazepine, Cocaine, Methamphetamine, MDMA, Opiates, Methadone, Oxycodone, Phencyclidine, Marijuana and their metabolites in human urine at the following cutoff levels: Test Calibrator Cut-off Amphetamine D-Amphetamine 1000 ng/mL Barbiturates Secobarbital 300 ng/mL Benzodiazepine Oxazepam 300 ng/mL Cocaine Benzoylecgonine 300 ng/mL Methamphetamine D-Methamphetamine 1000 ng/mL Methadone Methadone 300 ng/mL MDMA D, L-MDMA 500 ng/mL Opiates 300 Morphine 300 ng/mL Opiates 2000 Morphine 2000 ng/mL Oxycodone Oxycodone 100 ng/mL Phencyclidine Phencyclidine 25 ng/mL Cannabinoids 11-nor-A 9-THC-9 COOH 50 ng/mL The tests provide only preliminary data, which should 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 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/K050540
Methodology: https://510kreport.com/methodology