AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup
Device Facts
| Record ID | K261984 |
|---|---|
| Device Name | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test Cup |
| Applicant | Assure Tech., LLC |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Jul 17, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
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: [Table of cut-offs]. 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: [Table of cut-offs]. 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.
Device Story
Single-use, lateral flow immunochromatographic urine test cups; detect multiple drugs of abuse simultaneously. Urine sample migrates via capillary action; target drugs compete with drug-conjugates for binding sites on monoclonal mouse antibody-coated particles. Presence of drug above cutoff saturates binding sites, preventing formation of visible test line; absence of drug allows line formation. Control line indicates proper test function. Used in OTC settings; operated by lay users. Provides preliminary results; requires professional confirmatory testing (GC/MS or LC/MS) for clinical decision-making. Benefits include rapid, point-of-care screening for drug presence.
Clinical Evidence
No clinical studies performed. Evidence consists of analytical performance data (precision, stability, interference, specificity) and a lay-user study (n=140) comparing device results to LC/MS-confirmed concentrations. Lay-user study demonstrated high agreement across various drug concentrations relative to cutoffs.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Components: test device, desiccant, aluminum pouch. Qualitative detection. No electronic energy source. Standalone, single-use diagnostic device.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, EDDP, Fentanyl, Ecstasy, Propoxyphene, Morphine, Methadone, Phencyclidine, Oxycodone, Norfentanyl, Methamphetamine, Nortriptyline, 6-Monoacetylmorphine, Tramadol, Marijuana) in human urine. Intended for OTC use as a preliminary screening tool. Requires confirmatory testing (GC/MS or LC/MS) for positive results.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
