# K233062: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx

- Pathway: 510(k) (Traditional)
- Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
- Decided: Nov 2, 2023 after 37 days
- Product code: NFT (Test, Amphetamine, Over The Counter)
- 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: 8 generations back to K945610 (1995). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202567: Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx, Guangzhou Wondfo Biotech Co., Ltd. (2020) Summary page 8.

## Most influential descendants
- K261280: BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel (2026), 0 descendants of its own

## Indications for use
BioSieveTM Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine (AMP) 1000 ng/mL or 500 ng/mL Buprenorphine (BUP) 10 ng/mL Secobarbital (BAR) 300 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 300 ng/mL or 150 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methamphetamine (MET) 1000 ng/mL or 500 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Morphine (MOP 300/OPI 2000) 2000 ng/mL or 300 ng/mL Methadone (MTD) 300 ng/mL Oxycodone (OXY) 100 ng/mL Phencyclidine (PCP) 25 ng/mL Propoxyphene (PPX) 300 ng/mL Nortriptyline (TCA) 1000 ng/mL Marijuana (THC) 50 ng/mL BioSieveTM Multi-Drug Urine Test Panel offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. BioSieveTM Multi-Drug Urine Test Panel Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2- ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in human urine at the cutoff concentrations of: Drug Calibrator Cut-off (ng/mL) Amphetamine (AMP) D-Amphetamine 1,000 or 500 Barbiturates (BAR) Secobarbital 300 Buprenorphine (BUP) Buprenorphine 10 Oxazepam (BZO) Oxazepam 300 Cocaine (COC ) Benzoylecgonine 300 or 150 2-ethylidene-1,5-dimethyl-3,3- 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine (EDDP) 300 diphenylpyrrolidine Ecstasy (MDMA) D,L- Methylenedioxy-methamphetamine 500 Methamphetamine (MET) D-Methamphetamine 1,000 or 500 Morphine (MOP/OPI ) Morphine 2,000 or 300 Methadone (MTD) Methadone 300 Oxycodone (OXY ) Oxycodone 100 Phencyclidine (PCP) Phencyclidine 25 Propoxyphene (PPX) Propoxyphene 300 Nortriptyline (TCA) Nortriptyline 1,000 Marijuana (THC ) 11-nor-Δ9-THC-9 COOH 50 BioSieveTM Multi-Drug Urine Test Panel Rx offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for prescription use. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Source page: https://510kreport.com/device/K233062
Methodology: https://510kreport.com/methodology