# K180878: BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Venture Bio-Tech Co., Ltd.
- Decided: Dec 17, 2018 after 258 days
- Product code: DJC (Thin Layer Chromatography, Methamphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3610
- 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 Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette 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 The cassette test may be configured as single drug test in any drug analytes listed in the table. 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 Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette 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 The cassette test may be configured as single drug test in any drug analytes listed in the table. 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/K180878
Methodology: https://510kreport.com/methodology