510(k) · Cleared
ClearedAssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Assure Tech., LLC · NFT Test, Amphetamine, Over The Counter
Cleared on Jul 17, 2026 as substantially equivalent to K252259 (Assure Tech., LLC, 2025) after a 35-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Jul 17, 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 backK181768 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- 2 generations backK243996 AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech…Assure Tech., LLC · 2025
- 1 generation backK252259 AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupAssure Tech., LLC · 2025
- This deviceK261984 AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC · 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 backK181768 AssureTech Panel Dip Tests, AssureTech Quick Cup TestsAssure Tech. (Hangzhou) Co, Ltd. · 2018
- 2 generations backK243996 AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech…Assure Tech., LLC · 2025
- 1 generation backK252259 AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupAssure Tech., LLC · 2025
- This deviceK261984 AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupAssure Tech., LLC · 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 | K181768 | AssureTech Panel Dip Tests, AssureTech Quick Cup Tests | Assure Tech. (Hangzhou) Co, Ltd. | 2018 | — |
| −2 | K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug… | Assure Tech., LLC | 2025 | — |
| −1 | K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | 2025 | — |
| 0 (this device) | K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup | Assure Tech., LLC | 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 |
|---|---|---|---|
| * | K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupSummary page 7…II 21 CFR, 862.3700 Toxicology (91) Propoxyphene Propoxyphene Test System 5. Predicate Devices: K252259 AssureTech Quick Cup Tests 6. Indications for Use The AssureTech Quick Cup Tests are competitive binding, lateral flow imm… | 2025 |
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 3.3 years on median.
- 2 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?
The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of: Drug (Identifier) Cut-off…
Read the full statement (479 words)
The AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:
Drug (Identifier) Cut-off level
Amphetamine(AMP) 1000 ng/mL or 500 ng/mL or 300 ng/mL
Secobarbital (BAR) 300 ng/mL
Buprenorphine(BUP) 10 ng/mL
Oxazepam (BZO) 300 ng/mL
Cocaine(COC) 300 ng/mL or 150 ng/mL
EDDP 300 ng/mL
Fentanyl (FYL) 1 ng/mL
Ecstasy (MDMA) 500 ng/mL
Propoxyphene (PPX) 300 ng/mL
Morphine (MOR) 2000 ng/mL or 300 ng/mL
Methadone(MTD) 300 ng/mL
Phencyclidine (PCP) 25 ng/mL
Oxycodone (OXY) 100 ng/mL
Norfentanyl (NFYL) 5 ng/mL
Methamphetamine(MET) 1000 ng/mL or 500 ng/mL or 300 ng/mL
Nortriptyline (TCA) 1000 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Tramadol (TML) 100 ng/mL
Marijuana (THC) 50 ng/mL or 20 ng/mL
The single or multi-test cup can include any combination of the analytes listed above. However, only one cut-off concentration can be included per analyte per device.
The test may yield positive results for the prescription drugs above when taken at or above prescribed doses. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
The AssureTech Multi-drug Urine Test Cup are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol and Marijuana in human urine at the cutoff concentrations of:
Drug (Identifier) Calibrator Cut-off level
Amphetamine(AMP) d-Amphetamine 1000 ng/mL or 500 ng/mL or 300 ng/mL
Secobarbital (BAR) Secobarbital 300 ng/mL
Buprenorphine(BUP) BUP-3-D-Glucuronide 10 ng/mL
Oxazepam (BZO) Oxazepam 300 ng/mL
Cocaine(COC) Benzoylecgonine 300 ng/mL or 150 ng/mL
EDDP 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine 300 ng/mL
Fentanyl (FYL) Fentanyl 1 ng/mL
Ecstasy (MDMA) 3,4-Methylenediioxy-MET 500 ng/mL
Propoxyphene (PPX) D-Propoxyphene 300 ng/mL
Morphine (MOR) Morphine 2000 ng/mL or 300 ng/mL
Methadone(MTD) Methadone 300 ng/mL
Phencyclidine (PCP) Phencyclidine 25 ng/mL
Oxycodone (OXY) Oxycodone 100 ng/mL
Norfentanyl (NFYL) Norfentanyl 5 ng/mL
Methamphetamine(MET) Methamphetamine 1000 ng/mL or 500 ng/mL or 300 ng/mL
Nortriptyline (TCA) Nortriptyline 1000 ng/mL
6-Monoacetylmorphine (6-MAM) 6-Monoacetylmorphine 10 ng/mL
Tramadol (TML) Cis-Tramadol 100 ng/mL
Marijuana (THC) 11-nor-9-THC-9-COOH 50 ng/mL or 20 ng/mL
The single or multi-test cup can include any combination of the analytes listed above, with and without on-board adulteration tests. However, only one cut-off concentration can be included per analyte per device. It is for in vitro diagnostic use only.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261984 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261984: AssureTech Quick Cup Tests;AssureTech 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/K261984
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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