# K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard

- Pathway: 510(k) (Traditional)
- Applicant: Co-Innovation Biotech Co., Ltd.
- Decided: Dec 11, 2014 after 73 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: 6 generations back to K945610 (1995). 27 ancestors in all.
13 later devices descend from it; 2 cite it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122809: Advin Multi-Drug Screen Test Cassette, Dip Card and Cup, Advin Biotech (2013) Summary page 6.

## Most influential descendants
- K153050: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard (2016), 11 descendants of its own
- K182530: BIOEASY Multi-Drug Test Cup (2018), 5 descendants of its own
- K192515: BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 (2019), 1 descendant of its own
- K192301: BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip (2019), 1 descendant of its own
- K180349: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests (2018), 1 descendant of its own

## Indications for use
Rapid Single/Multi-drug test Cup and Rapid 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 the following cut-off concentrations: Test Calibrator Cut-off level Marijuana (THC) Delta-9-THC-COOH 50ng/mL Cocaine (COC) Benzolecgonine 300ng/mL Amphetamine (AMP) D-Amphetamine 1000ng/mL Methamphetamine (MET) D-Methamphetamine 1000ng/mL Morphine 2000 (MOP) Morphine 2000ng/mL Barbiturates (BAR) Secobarbital 300ng/mL Benzodiazepines (BZO) Oxazepam 300ng/mL Methylenedioxymethamphetamine (MDMA) 3,4-Methylenedioxymethamphetamine 500ng/mL Methadone (MTD) Methadone 300ng/mL Oxycodone (OXY) Oxycodone 100ng/mL Phencyclidine (PCP) Phencyclidine 25ng/mL The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use. The tests will yield preliminary positive results when prescription drugs Barbiturates, Benzodiazepine, and Methadone are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates and Benzodiazepine in urine. The assays provide 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/K142800
Methodology: https://510kreport.com/methodology