BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx
Device Facts
| Record ID | K233062 |
|---|---|
| Device Name | BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx |
| Applicant | Vivachek Biotech (Hangzhou) Co., Ltd. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Nov 2, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Indications for Use
BioSieve™ 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 and Marijuana in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. BioSieve™ Multi-Drug Urine Test Panel offers any combinations from 1 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. It is intended for OTC use. The tests may yield positive results for the prescription drugs Buprenorphine, 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. Clinical consideration and professional 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.
Device Story
Rapid, single-use lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine. Input: urine sample; Principle: competitive binding antigen-antibody reaction. If drug concentration is below cutoff, target drug does not saturate antibody-coated particles, allowing capture by immobilized drug-conjugate to form a visible colored test line. If concentration exceeds cutoff, binding sites are saturated, preventing test line formation. Control line confirms proper test performance. Used in OTC or clinical settings; operated by patients or healthcare providers. Output: visual qualitative result (positive/negative). Results are preliminary; requires GC/MS or LC/MS confirmation. Benefits: rapid, simultaneous screening for multiple substances to aid clinical decision-making.
Clinical Evidence
Bench testing only. Performance validated via precision studies (25 days, 3 lots), interference studies (100+ compounds), specificity/cross-reactivity, and method comparison against LC/MS. Lay-user study (n=280) confirmed ease of use and performance across diverse demographics. No clinical prospective/retrospective trials required for this device class.
Technological Characteristics
Lateral flow immunochromatographic assay. Single-use test panel format. Materials: test strip, desiccant, pouch. Energy source: none (capillary action). Connectivity: none. Sterilization: not stated. Software: none.
Indications for Use
Indicated for the qualitative, simultaneous detection of 15 drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana) in human urine. Intended for OTC or prescription use. Not intended to distinguish between prescription use and 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).
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