# K153050: Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard

- Pathway: 510(k) (Special)
- Applicant: Co-Innovation Biotech Co., Ltd.
- Decided: Apr 26, 2016 after 189 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
Longest line of descent: 7 generations back to K945610 (1995). 29 ancestors in all.
11 later devices descend from it; 5 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)
- K140748: One Step Single/Multi-Drug Test Cup, One Step Single/Multi-Drug Test Dipcard, Co-Innovation Biotech Co., Ltd. (2014) Summary page 6.
- K142800: Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard, Co-Innovation Biotech Co., Ltd. (2014) Summary page 6.

## Most influential descendants
- 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
- K232228: Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card (2024), 0 descendants of its own

## Indications for use
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test 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 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 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 Buprenorphine(BUP) Buprenorphine 10ng/mL 2-ethylidene-1, 5-dimethyl-3, 2-ethylidene-1, 5-dimethyl-3, 300 ng/mL 3-diphenylpyrrolidine(EDDP) 3-diphenylpyrrolidine Morphine(MOP300) Morphine 300 ng/mL Propoxyphene(PPX) Propoxyphene 300 ng/mL Tri-cyclic Antidepressants (TCA) Nortriptyline 1000 ng/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 up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The 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, Buprenorphine, Benzodiazepine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine. 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/K153050
Methodology: https://510kreport.com/methodology