# K132812: Ucp Multi-Drug Test Key Cups

- Pathway: 510(k) (Traditional)
- Applicant: Ucp Biosciences, Inc.
- Decided: Mar 6, 2014 after 178 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: 2 generations back to K091588 (2009). 3 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130463: Ucp Home Drug Screening Test; Cards, Cups, Ucp Biosciences, Inc. (2013) Summary page 2.

## Most influential descendants
- K150791: Healgen Secobarbital Test (Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) (2015), 3 descendants of its own
- K142609: CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (2014), 1 descendant of its own
- K163704: Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip Card (2017), 0 descendants of its own
- K153597: Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (2016), 0 descendants of its own
- K151642: Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card (2015), 0 descendants of its own

## Indications for use
The UCP Multi-Drug Test Key Cups are rapid tests for preliminary detection of the following drugs in human urine: Test Calibrated to Cut-off Amphetamine D-Aniphetamine 1000 ng/mL Barbiturates Secobarbital 300 nglmL Benzodiazepines Oxazepam 300 nglmL Buprenorphine Buparenorphine 10 nglmL Cocaine Benzoylecgonine 300 nglmL Marijuana Delta-9-TI4C-COQH 50 ng/mL Methadone Methadone 300 ng/mL Methainphetamine D*Methamphelamine 1000 nglmL MDMA MDMA 500 nglmL Morphine Morphine 300 nglmL Opiates 2000 Morphine 2000 og/niL Oxycodone Oxycodlonc 100 nglmL Phencyclidine Phencyclidine 25 ng/mL Propoxyphene Propoxyphene 300 ng/mL Tricyclic Antidepressant Nortriptyline 1000 nglmL The test configuration comes with a 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 in a urine sample. The second step is to send preliminary positive samples for confirmation testing by GCMS. The test is not intended to distinguish between prescription use or abuse of the following drugs: Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressants. There are no uniformly recognized cutoff concentration levels for Barbiturate, Benzodiazepines, Buprenorphine, Oxycodlone, Propxyphene, Tricyclic Antidepressant in urine. Clinical considerations and professional judgment should be applied to any drug of abuse test results, particularly when preliminary positive results are indicated.

Source page: https://510kreport.com/device/K132812
Methodology: https://510kreport.com/methodology