# K261280: BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel

- Pathway: 510(k) (Traditional)
- Applicant: Vivachek Biotech (Hangzhou) Co., Ltd.
- Decided: May 22, 2026 after 35 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: 9 generations back to K945610 (1995). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233062: BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx, Vivachek Biotech (Hangzhou) Co., Ltd. (2023) Summary page 7.

## 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, Cannabinoids, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of: Drug Calibrator Cut-off (ng/mL) Amphetamine (AMP) D-Amphetamine 1,000 or 500 Secobarbital (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- 300 diphenylpyrrolidine (EDDP) 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 Marjuana (THC ) 11-nor-Δ9-THC-9 COOH 50 Tramadol (TRA) Tramadol 100 Fentanyl (FYL) Fentanyl 1 6-Monoacetylmorphine (6-MAM) 6-Monoacetylmorphine 10 Norfentanyl (NFYL) Norfentanyl 5 The single or multi-test panel can consist of up to nineteen (19) of the above listed analytes in any combination. It is for in vitro diagnostic use only. 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. Careful consideration and 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 Home Test Panel is competitive binding, lateral flow immunochromatographic assay 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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off level Amphetamine (AMP) 500 ng/mL or 1000 ng/mL Buprenorphine (BUP) 10 ng/mL Secobarbital (BAR) 300 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 150 ng/mL or 300 ng/mL 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL Methamphetamine (MET) 500 ng/mL or 1000 ng/mL Methylenedioxymethamphetamine (MDMA) 500 ng/mL Morphine (MOP 300/OPI 2000) 300 ng/mL or 2000 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 Tramadol (TRA) 100 ng/mL Fentanyl (FYL) 1 ng/mL 6-Monoacetylmorphine (6-MAM) 10 ng/mL Norfentanyl (NFYL) 5 ng/mL The single or multi-test panel can consist of up to nineteen (19) of the above listed analytes in any combination. It is for in vitro diagnostic use only. It is intended for OTC use. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Careful consideration and 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 alternative chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Source page: https://510kreport.com/device/K261280
Methodology: https://510kreport.com/methodology