510(k) · Cleared
ClearedWisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup
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 Sep 12, 2025 as substantially equivalent to K222667 (Vivachek Biotech (Hangzhou) Co., Ltd., 2022) after a 30-day review. Its family tree reaches back 8 generations to 1995.
- Decided
- Sep 12, 2025
- Review
- 30 days
- Class
- Class II
- Product code
- NFT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K945610 (1995). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK945610 Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM)…Princeton BioMeditech Corp. · 1995
- 7 generations backK011673 Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step…ACON Laboratories, Inc. · 2001
- 6 generations backK020313 Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step…Acon Laboratories Co. · 2002
- 5 generations backK031759 Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon…ACON Laboratories, Inc. · 2003 · Recalled
- 4 generations backK061718 Innovacon Spectrum II Test CardInnovacon, Inc. · 2006 · Recalled
- 3 generations backK122809 Advin Multi-Drug Screen Test Cassette, Dip Card and CupAdvin Biotech · 2013
- 2 generations backK182701 Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd. · 2018 · Recalled
- 1 generation backK222667 Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup…Vivachek Biotech (Hangzhou) Co., Ltd. · 2022
- This deviceK252554 Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home…Vivachek Biotech (Hangzhou) Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K945610 | Abusign (TM) Amp, Doa-Amp, Accusign (TM) Amp-Doa-Amp, Biosign (TM) Amp, Doa-Amp | Princeton BioMeditech Corp. | 1995 | — |
| −7 | K011673 | Acon Amp One Step Amphetamine Test Strip, Acon Amp One Step Amphetamine Test… | ACON Laboratories, Inc. | 2001 | — |
| −6 | K020313 | Acon One Step Multi-Drug Multi-Line Screen Test Card; Acon One Step Multi-Drug… | Acon Laboratories Co. | 2002 | — |
| −5 | K031759 | Acon Spectrum Multi-Drug Multi-Line Drug Screen Test Card and Acon Spectrum… | ACON Laboratories, Inc. | 2003 | 1 |
| −4 | K061718 | Innovacon Spectrum II Test Card | Innovacon, Inc. | 2006 | 6 |
| −3 | K122809 | Advin Multi-Drug Screen Test Cassette, Dip Card and Cup | Advin Biotech | 2013 | — |
| −2 | K182701 | Wondfo T-Cup Multi-Drug Urine Test Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2018 | 1 |
| −1 | K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx | Vivachek Biotech (Hangzhou) Co., Ltd. | 2022 | — |
| 0 (this device) | K252554 | Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup | Vivachek Biotech (Hangzhou) Co., Ltd. | 2025 | — |
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 |
|---|---|---|---|
| * | K222667 | Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup RxSummary page 7…NFW 862.3870, Cannabinoids Toxicology Cannabinoids (THC 50) Test System 6. Predicate Device K222667 Wisdiag Multi-Drug Urine Test Cup and Wisdiag Multi-Drug Urine Test Cup Rx 7. Intended U… | 2022 |
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 30 years and passes through 7 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 29 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. 2025, 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?
Wisdiag Multi-Drug Urine Test Cup 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, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl…
Read the full statement (473 words)
Wisdiag Multi-Drug Urine Test Cup 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, 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 (TML) 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 cups can consist of up to nineteen (19) of the above listed analytes in any combination but only
one cutoff concentration under same drug condition will be included per device with or without on-board
adulteration/specimen validity tests (SVT).
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. Careful consideration and judgment
should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Wisdiag Multi-Drug Urine Home Test Cup 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, 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 (TML) 100 ng/mL
Fentanyl (FYL) 1 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Norfentanyl (NFYL) 5 ng/mL
Wisdiag Multi-Drug Urine Home Test Cup offers any combinations from 1 to 19 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
to be over-the-counter use.
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. Careful consideration and judgment
should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252554: Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home 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/K252554
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026