510(k) · Cleared
ClearedBioTeke® Multi-Drug Urine Test Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioteke Corporation (Wuxi) Co., Ltd. · NFT Test, Amphetamine, Over The Counter
Cleared on Sep 10, 2026 as substantially equivalent to K241428 (Hangzhou AllTest Biotech Co., Ltd., 2024) after a 133-day review. Its family tree reaches back 10 generations to 2000.
- Decided
- Sep 10, 2026
- Review
- 133 days
- Class
- Class II
- Product code
- NFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K001178 (2000). 20 ancestors in all, the oldest K971218 (1997). No later device cites it as a predicate yet.
- Root · 10 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 6 generations between
- 3 generations backK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
- 2 generations backK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023
- 1 generation backK241428 AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine…Hangzhou AllTest Biotech Co., Ltd. · 2024
- This deviceK261409 BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK001178 Cedia Dau 6-Acetylmorphine AssayMicrogenics Corp. · 2000
- 9 generations backK040316 Cedia Buprenorphine AssayMicrogenics Corp. · 2004
- 8 generations backK042988 Rapid One Step Buprenorphine Test CardTianjin New Bay Bioresearch Co., Ltd. · 2005
- 7 generations backK060527 Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine…Alfa Scientific Designs, Inc. · 2006
- 6 generations backK063545 Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine…Alfa Scientific Designs, Inc. · 2007
- 5 generations backK152122 Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View…Alfa Scientific Designs, Inc. · 2016
- 4 generations backK173303 INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC…Alfa Scientific Designs, Inc. · 2018
- 3 generations backK182738 Single and Multi-Drug Rapid Test Panel With Adulteration (Urine)…Hangzhou AllTest Biotech Co., Ltd. · 2019
- 2 generations backK233019 AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test…Hangzhou AllTest Biotech Co., Ltd. · 2023
- 1 generation backK241428 AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine…Hangzhou AllTest Biotech Co., Ltd. · 2024
- This deviceK261409 BioTeke® Multi-Drug Urine Test CupBioteke Corporation (Wuxi) Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K001178 | Cedia Dau 6-Acetylmorphine Assay | Microgenics Corp. | 2000 | — |
| −9 | K040316 | Cedia Buprenorphine Assay | Microgenics Corp. | 2004 | — |
| −8 | K042988 | Rapid One Step Buprenorphine Test Card | Tianjin New Bay Bioresearch Co., Ltd. | 2005 | — |
| −7 | K060527 | Instant-View Bup/Nbup Urine Test. Instant-Verdict Bup/Nbup Urine Test… | Alfa Scientific Designs, Inc. | 2006 | — |
| −6 | K063545 | Multi-Drug of Abuse Urine Test,Urine Cup Test, Amphetamine Urine Test… | Alfa Scientific Designs, Inc. | 2007 | — |
| −5 | K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug… | Alfa Scientific Designs, Inc. | 2016 | — |
| −4 | K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use)… | Alfa Scientific Designs, Inc. | 2018 | — |
| −3 | K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and… | Hangzhou AllTest Biotech Co., Ltd. | 2019 | — |
| −2 | K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel… | Hangzhou AllTest Biotech Co., Ltd. | 2023 | — |
| −1 | K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test Cup | Hangzhou AllTest Biotech Co., Ltd. | 2024 | — |
| 0 (this device) | K261409 | BioTeke® Multi-Drug Urine Test Cup | Bioteke Corporation (Wuxi) Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2004 | 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 |
|---|---|---|---|
| * | K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupSummary page 6…862.3870 Cannabinoids Test Toxicology System Toxicology 6. Predicate Devices: AllTest Multi-Drug Urine Test Cup (K241428) 7. Intended Use BioTeke® Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay. It is a r… | 2024 |
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 26 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 20 ancestors has a recall.
- 1 other device also cites its predicate K241428.
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?
BioTeke® Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay. It is a rapid drug test for the qualitative and simultaneous detection of drugs and drug metabolites in human urine. It is for in vitro diagnostic use only. Prescription Use Only. Drug test cut-off concentrations are listed below: Test Calibrator Cut-off (ng/mL) Amphetamine (AMP) Amphetamine 500 Phenobarbital (BAR) Phenobarbital 300 Buprenorphine (BUP)…
Read the full statement (161 words)
BioTeke® Multi-Drug Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay. It is a rapid drug test for the qualitative and simultaneous detection of drugs and drug metabolites in human urine. It is for in vitro diagnostic use only. Prescription Use Only. Drug test cut-off concentrations are listed below:
Test Calibrator Cut-off (ng/mL)
Amphetamine (AMP) Amphetamine 500
Phenobarbital (BAR) Phenobarbital 300
Buprenorphine (BUP) Buprenorphine 10
Oxazepam (BZO) Oxazepam 300
Cocaine (COC) Benzoylecgonine 150
Fentanyl (FTY) Fentanyl 1
Methylenedioxymethamphetamine (MDMA) Methylenedioxymethamphetamine 500
Methamphetamine (MET) Methamphetamine 500
Morphine (MOP/OPI) Morphine 300
Methadone (MTD) Methadone 300
Oxycodone (OXY) Oxycodone 100
Phencyclidine (PCP) Phencyclidine 25
Marijuana (THC) 11-nor-Δ9-THC-9-COOH 50
Nortriptyline (TCA) Nortriptyline 1000
BioTeke® Multi-Drug Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. The test provides only preliminary test results. A more specific method must be used in order to obtain a confirmed result. GC/MS or LC/MS is the preferred method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261409 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261409: BioTeke® Multi-Drug Urine Test Cup.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261409
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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