# K131110: One Step Single/Multi-Drug Test Cup; One Step Single Single/Multi-Drug Test Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Co-Innovation Biotech Co., Ltd.
- Decided: Jan 15, 2014 after 271 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
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 immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at or above the following cut-off concentrations: Test Calibrator Cut-off level Marijuana (THC) Delta-9-THC-COOH 50 ng/mL Cocaine (COC) Benzoylecgonine 300 ng/mL Amphetamine (AMP) D-Amphetamine 1000 ng/mL Methamphetamine (MET) D-Methamphetamine 1000 ng/mL Morphine 2000 (MOP) Morphine 2000 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. These tests provide only a preliminary analytical test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained with the One Step Multi-drug Test Cup Insert or One Step Single/Multi-drug Test Dipcard Insert, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. 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/K131110
Methodology: https://510kreport.com/methodology