# K122419: Ucp Home Drug Screening Test Cups

- Pathway: 510(k) (Traditional)
- Applicant: Ucp Biosciences, Inc.
- Decided: Nov 30, 2012 after 113 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: 1 generation back to K091588 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091588: Ucp Home Drug Screening Tests, Ucp Biosciences, Inc. (2009) Summary page 2.

## Indications for use
The UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding inmmoassays 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 ng/mL Cocaine Benzoylecgonine 300 ng/mL Marijuana Delta-9-THC-COOH 50 nglmL Methadone Methadone 300 ng/mL Methamphetamine D-Methamphetamine 1000 ng/mL MDMA MDMA 500 nglmL Morphine Morphine 300 ng/mL Opiates 2000 Morphine 2000 ng/mL *Oxycodone Oxycodone 100 nglmL Phencyclidine Phencyclidine 25 ng/mL Tricyclic Antidepressant Nortiptyline 1000 ng/mL 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, 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. Ttests 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 provide only preliminary data, which should be confirmed by other methods such as gas chromatography/mass spectrometry (GCIMS). 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/K122419
Methodology: https://510kreport.com/methodology