# K140215: One Step Single/Multi-Drug Test Cup/Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Co-Innovation Biotech Co., Ltd.
- Decided: Jun 16, 2014 after 139 days
- Product code: DIS (Enzyme Immunoassay, Barbiturate)
- Device class: 2
- Regulation: 21 CFR 862.3150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K091588 (2009). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091588: Ucp Home Drug Screening Tests, Ucp Biosciences, Inc. (2009) Summary page 2.

## Indications for use
One Step Single/Multi-drug Test Cup and One Step Single/Multi-drug Test Dipcard are lateral flow chromatographic immunoassay designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations: Test | Calibrator | Cut-off level Barbiturates (BAR) | Secobarbital | 300 ng/mL Benzodiazepines (BZO) | Oxazepam | 300 ng/mL Methylenedioxymethamphetamine (MDMA) | 3,4-Methylenedioxymethamphetamine | 500 ng/mL Methadone (MTD) | Methadone | 300 ng/mL Oxycodone (OXY) | Oxycodone | 100 ng/mL Phencyclidine (PCP) | Phencyclidine | 25 ng/mL The tests contain two formats: 1) Test Cup, 2) Test Dipcard. 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. They are intended for prescription use in clinical laboratories only and not for point-of-care use. This assay provides only a preliminary analytical test result. Gas Chromatography/Mass spectrometry (GC/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.

Source page: https://510kreport.com/device/K140215
Methodology: https://510kreport.com/methodology