Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)
Device Facts
| Record ID | K152122 |
|---|---|
| Device Name | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) |
| Applicant | Alfa Scientific Designs, Inc. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Jun 24, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
The Instant-View® Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use) are rapid, qualitative immunoassays for the detection in human urine of one or more of the drugs at the cutoff concentrations listed below. These devices will detect up to 13 of the drugs below in any combination. The tests are not intended to distinguish prescription use or abuse of any drugs. These devices provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained. This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. Tests for prescription drugs will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.
Device Story
Lateral flow chromatographic immunoassay; detects drugs in human urine. Device consists of 1-13 test strips; each strip contains conjugate pad with colloidal gold-labeled anti-drug antibodies and nitrocellulose membrane with test (T) and control (C) lines. User applies urine sample; capillary action moves sample across membrane. Competitive binding principle: drug in sample competes with conjugated drug antigen for antibody binding sites. Absence of T-line indicates presence of drug above cutoff; presence of T-line indicates drug absence or concentration below cutoff. C-line confirms proper liquid flow. Used in home setting by lay users. Provides preliminary results; requires confirmatory testing (e.g., GC/MS) for clinical decision-making. Benefits include rapid, accessible information for consumers regarding potential drug presence.
Clinical Evidence
Lay-user study (n=400) across three sites; participants (18 to >60 years) with no prior OTC test experience. Samples spiked with drugs at 0%, 50%, 75%, 125%, and 150% of cutoff concentrations. Results compared to GC/MS. Average interpretation agreement >96%. Survey data indicates high ease-of-use and understanding of labeling (Flesch-Kincaid grade level 7).
Technological Characteristics
Lateral flow immunochromatographic assay. Competitive binding principle. Components: conjugate pad with colloidal gold-labeled anti-drug antibodies; nitrocellulose membrane with immobilized drug-specific conjugate (T-line) and control line (C-line). Form factors: test cup and panel cassette. Storage: 2°C to 30°C. Shelf life: 24 months. No electronic components or software.
Indications for Use
Indicated for OTC qualitative detection of up to 13 drugs/metabolites in human urine (Amphetamine, Barbiturates, Buprenorphine, Benzodiazepine, Cocaine, Methamphetamine, Methadone, Phencyclidine, Tricyclic antidepressants, Cannabinoid, MDMA, Morphine, Oxycodone) at specified cutoff concentrations. Intended for use by consumers (e.g., parents) as a preliminary screening tool; not for distinguishing prescription use from abuse.
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).
Predicate Devices
- Instant-View Multi-Drug of Abuse Urine Test Devices/Cup (k063545)
- Instant-View Multi-Drug of Abuse Urine Test Devices/Cassettes (k063545)
