# K131811: Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups

- Pathway: 510(k) (Special)
- Applicant: Ucp Biosciences, Inc.
- Decided: Jul 19, 2013 after 30 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K152908: Ucp Compact Drug Tests (2016), 0 descendants of its own

## Indications for use
The UCP Compact Drug Test Cards and UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: Drug — Calibrator — Cutoff Amphetamine — D-Amphetamine — 1000 ng/mL Barbiturates — Secobarbital — 300 ng/mL Benzodiazepiies — Oxazepam — 300 ng/mL Buprenorphine — Buprenarphine — 10 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 Opiates 2000 — Morphine — 2000 ng/mL Oxycodone — Oxycodone — 100 ng/mL Phencyclidine — Phencyclidine — 25 ng/mL Propoxyphene — Propoxyphene — 300 mg/mL Tricyclic Antidepressants — 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. The tests will yield preliminary positive results when the prescription drugs Barbiturates, Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene, Tricyclic Antidepressanits 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 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/K131811
Methodology: https://510kreport.com/methodology