# K091612: Ucp Rapid Drug Screening Buprenorphine, Amp 300, Mamp 500, Coc 150 Test;

- Pathway: 510(k) (Traditional)
- Applicant: Ucp Biosciences, Inc.
- Decided: Feb 24, 2010 after 266 days
- Product code: DJG (Enzyme Immunoassay, Opiates)
- Device class: 2
- Regulation: 21 CFR 862.3650
- 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. The FDA summary names its predicate without a number.
- (no number) ACON BUP One Step Buprenorphine Test Strip: named in the summary without a submission number
- (no number) ACON BUP One Step Buprenorphine Test Device: named in the summary without a submission number
- (no number) ACON AMP-300 One Step Amphetamine Test Strip: named in the summary without a submission number
- (no number) ACON AMP-300 One Step Amphetamine Test Device: named in the summary without a submission number
- (no number) ACON mAMP-500 One Step Methamphetamine Test Strip: named in the summary without a submission number
- (no number) ACON mAMP-500 One Step Methamphetamine Test Device: named in the summary without a submission number
- (no number) ACON COC-150 One Step Cocaine Test Strip: named in the summary without a submission number
- (no number) ACON COC-150 One Step Cocaine Test Device: named in the summary without a submission number

## Indications for use
The UCP Drug Screening Buprenorphine, Amphetamine 300, Methamphetamine 500, Cocaine 150 Tests are rapid, qualitative, competitive binding immunoassays for the detection the following drug in human urine: Test Calibrator Cut-off Buprenorphine Buprenorphine 10 ng/mL Amphetamine D-Amphetamnine 300 ng/mL Methamphetarnine D-Methamphetamine 500 ng/mL Cocaine Benzoylecgonine 150 ng/mL The tests contain three formats: 1) Test Card/Strip; 2) Test Device, 3) Test Cup. The test configuration comes with single drug screening test or any combinations of multiple drug screening tests. The test is intended for in vitro diagnostics use. 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) or Liquid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method. 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/K091612
Methodology: https://510kreport.com/methodology