# K261984: AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Assure Tech., LLC
- Decided: Jul 17, 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)
- K252259: AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup, Assure Tech., LLC (2025) Summary page 7.

## Indications for use
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.

Source page: https://510kreport.com/device/K261984
Methodology: https://510kreport.com/methodology