← Product Code [NFT](/productcode/NFT) · K261280

# BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel (K261280)

_Vivachek Biotech (Hangzhou) Co., Ltd. · NFT · May 22, 2026 · Clinical Toxicology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K261280

## Device Facts

- **Applicant:** Vivachek Biotech (Hangzhou) Co., Ltd.
- **Product Code:** [NFT](/productcode/NFT.md)
- **Decision Date:** May 22, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.3100
- **Device Class:** Class 2
- **Review Panel:** Clinical Toxicology

## 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.

## 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)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: K261280

This 510(k) was reviewed under the OHT7'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.

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**Source:** [https://fda.innolitics.com/device/K261280](https://fda.innolitics.com/device/K261280)

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