# K123863: Ucp Compact Drug Test Cards, Ucp Compact Drug Test Cups

- Pathway: 510(k) (Special)
- Applicant: Ucp Biosciences, Inc.
- Decided: Jan 9, 2013 after 26 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The UCP Compact Drug Test Cards, UCP Compact Drug Test Cups are rapid, qualitative, competitive binding immunoassays for the detection of the following drugs and their metabolites in human urine: Test — Calibrator — Cut-off Amphetamine — D-Arnphetamine — 1000 ng/mL Barbiturates — Secobarbital — 300 ng/mL Benzodiazepines — Oxazepam — 300 ng/mL Cocaine — Benzoylecgonine — 300 nglmL Marijuana — Delta-9-THC-COOH — 50 nglmL Methadone — Methadone — 1300 nglmL Methamphetamine — D-Methamphetamine — 1000 ng/mL MDMA — MDMA — 500 ng/mL Morphine — Morphine — 300 nglmL Opiate 2000 — Morphine — 2000 nglmL Oxycodone — Oxycodone — 100 nglmL Phencyclidine — Phencyclidine — 25 ng/mL Tricyclic Antidepressant — Nortriptyline — 1000 nglmL 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, Oxycodone, Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no unifornly 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 (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/K123863
Methodology: https://510kreport.com/methodology