# K252259: AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Cup

- Pathway: 510(k) (Traditional)
- Applicant: Assure Tech., LLC
- Decided: Aug 15, 2025 after 25 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: 8 generations back to K945610 (1995). 29 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243996: AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup, Assure Tech., LLC (2025) Summary page 7.

## Most influential descendants
- K261984: AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup (2026), 0 descendants of its own

## 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) 500 ng/mL or 300 ng/mL Secobarbital (BAR) 300 ng/mL Buprenorphine (BUP) 10 ng/mL Oxazepam (BZO) 300 ng/mL Cocaine (COC) 150 ng/mL EDDP 300ng/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) 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 Configuration of the AssureTech Quick Cup Tests can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs above when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. 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 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 150 ng/mL EDDP 2-Ethylidine-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/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 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 Configuration of the AssureTech Multi-drug Urine Test Cup can consist of any combination of the above listed drug analytes. 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/K252259
Methodology: https://510kreport.com/methodology