510(k) · Cleared
ClearedBioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vivachek Biotech (Hangzhou) Co., Ltd. · NFT Test, Amphetamine, Over The Counter
Cleared on May 22, 2026 as substantially equivalent to K233062 (Vivachek Biotech (Hangzhou) Co., Ltd., 2023) after a 35-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- May 22, 2026
- Review
- 35 days
- Class
- Class II
- Product code
- NFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K945610 (1995). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 5 generations between
- 3 generations backK182701 Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · Recalled
- 2 generations backK202567 Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug…Guangzhou Wondfo Biotech Co., Ltd. · 2020
- 1 generation backK233062 BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine…Vivachek Biotech (Hangzhou) Co., Ltd. · 2023
- This deviceK261280 BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 8 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 7 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 6 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 5 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 4 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 3 generations backK182701 Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · Recalled
- 2 generations backK202567 Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug…Guangzhou Wondfo Biotech Co., Ltd. · 2020
- 1 generation backK233062 BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine…Vivachek Biotech (Hangzhou) Co., Ltd. · 2023
- This deviceK261280 BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home…Vivachek Biotech (Hangzhou) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −8 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −7 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −6 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −5 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −4 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −3 | K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | 1 |
| −2 | K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test… | Guangzhou Wondfo Biotech Co., Ltd. | 2020 | — |
| −1 | K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel… | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023 | — |
| 0 (this device) | K261280 | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel | Vivachek Biotech (Hangzhou) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NFT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NFT device
- #1 K244043 AllTest Multi-Drug Rapid Test Cup ; AllTest…score 20.3 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K233062 | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel RxSummary page 7…NFW 862.3870, Cannabinoids Toxicology Cannabinoids (THC 50) Test System 6. Predicate Device K233062 BioSieve Multi-Drug Urine Test Panel and BioSieve Multi-Drug Urine Test Panel Rx 7. Inte… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 7 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 30 ancestors have a recall of any class.
How does its category compare?
All NFT devicesNFT Test, Amphetamine, Over The Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NFT
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFT
37in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFT
No recall names NFT since 2007.
Adverse event reports per year · NFT
No MAUDE report names NFT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 6 | 56 | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 3 | 63 | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 4 | 31 | 0 | 0 |
| 2025 | 8 | 37 | 0 | 0 |
| 2026 | 5 | 35 | 0 | — |
What is it indicated for?
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…
Read the full statement (524 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261280: BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261280
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026