# K180879: BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Venture Bio-Tech Co., Ltd.
- Decided: Dec 14, 2018 after 255 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: 7 generations back to K001178 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173303: INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use), Alfa Scientific Designs, Inc. (2018) Summary page 6.

## Indications for use
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Test Calibrators Cut-off Level Amphetamine (AMP) d-Amphetamine 1000ng/ml Oxazepam Oxazepam 300ng/ml Cocaine (COC) Benzoylecgonine 300ng/ml Methamphetamine (MET) d-Methamphetamine 1000ng/ml Morphine(MOP) Morphine 300ng/ml Marijuana (THC) Delta-9-THC-COOH 50ng/ml Easy cup test and Split Key Cup test 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 6 analytes. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over the counter use. BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Test Calibrators Cut-off Level Amphetamine (AMP) d-Amphetamine 1000ng/ml Oxazepam Oxazepam 300ng/ml Cocaine (COC) Benzoylecgonine 300ng/ml Methamphetamine (MET) d-Methamphetamine 1000ng/ml Morphine(MOP) Morphine 300ng/ml Marijuana (THC) Delta-9-THC-COOH 50ng/ml Easy cup test and split key cup test 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 6 analytes. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use.

Source page: https://510kreport.com/device/K180879
Methodology: https://510kreport.com/methodology