← Product Code [NFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT) · K233062 # BioSieveTM Multi-Drug Urine Test Panel; BioSieveTM Multi-Drug Urine Test Panel Rx (K233062) _Vivachek Biotech (Hangzhou) Co., Ltd. · NFT · Nov 2, 2023 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT/K233062 ## Device Facts - **Applicant:** Vivachek Biotech (Hangzhou) Co., Ltd. - **Product Code:** [NFT](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT.md) - **Decision Date:** Nov 2, 2023 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3100 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology ## 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. ## Regulatory 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). ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} # 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION ## TRIAGE-QUICK REVIEW DECISION MEMORANDUM 510(k) Number: k233062 This 510(k) was reviewed under the OHT7/OHT8 OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA. The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination. --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT/K233062](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/NFT/K233062) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com