# K091588: Ucp Home Drug Screening Tests

- Pathway: 510(k) (Traditional)
- Applicant: Ucp Biosciences, Inc.
- Decided: Sep 4, 2009 after 94 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.
12 later devices descend from it; 4 cite it directly.
0 of 13 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) UCP Rapid Drug Screening Tests: named in the summary without a submission number
- (no number) UCP Rapid Drug Screening Tricyclic Antidepressants Tests: named in the summary without a submission number
- (no number) UCP Multiple Drug Screen Test Cups: named in the summary without a submission number

## Most influential descendants
- K130463: Ucp Home Drug Screening Test; Cards, Cups (2013), 8 descendants of its own
- K132812: Ucp Multi-Drug Test Key Cups (2014), 6 descendants of its own
- 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

## Indications for use
The UCP Home Drug Screening Test Cards and the UCP Home Drug Screening Test Cups are rapid, qualitative, competitive binding immunoassays 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 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 The tests contain two formats: 1) Test Card; 2) Test Cup., 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, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Infoemation regarding confirmatory testing - the second step in the process, along with the materialsfor shipping the urine specimen to the laboratory, is provided. The test is also intended for health care professional users. The tests 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 only provide a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method for most drugs (HPLC is the preferred confirmatory method for Tri-cyclicAntidepressants). Clinical consideration 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 drug levels.

Source page: https://510kreport.com/device/K091588
Methodology: https://510kreport.com/methodology