BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel
Device Facts
| Record ID | K261280 |
|---|---|
| Device Name | BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel |
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | May 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
BioSieveTM Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of: [Table of analytes and cutoffs]. The single or multi-test panel can consist of up to nineteen (19) of the above listed analytes in any combination. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Careful consideration and judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method. BioSieveTM Multi-Drug Urine Home Test Panel is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana, Tramadol, Fentanyl, 6-Monoacetylmorphine and Norfentanyl in human urine at the cutoff concentrations of: [Table of analytes and cutoffs]. The single or multi-test panel can consist of up to nineteen (19) of the above listed analytes in any combination. It is for in vitro diagnostic use only. It is intended for OTC use. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Careful consideration and judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Device Story
Rapid, single-use, lateral flow immunochromatographic assay; detects drugs of abuse in human urine. Sample migrates via capillary action; competitive binding mechanism; drug presence inhibits antibody-particle binding to immobilized drug-conjugate. Absence of test line indicates positive result; control line confirms proper function. Used in clinical or home settings; interpreted visually by user. Provides preliminary results; requires confirmatory testing for clinical decision-making. Benefits include rapid, accessible screening for drug presence.
Clinical Evidence
No clinical studies performed. Evidence consists of bench testing (precision, interference, specificity, method comparison against LC/MS) and a lay-user study (n=280) confirming performance across various concentrations and ease of use.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Single-use test panel format. Materials include test strip, housing, and desiccants. Stable at 2-30°C for 36 months. No electronic components or software.
Indications for Use
Indicated for qualitative, simultaneous detection of 19 drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana, Tramadol, Fentanyl, 6-MAM, Norfentanyl) in human urine. Intended for professional and OTC home use. Not for distinguishing prescription use from abuse. Requires confirmatory testing (GC/MS or LC/MS).
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).
