Cleared Traditional

K233062 - BioSieveTM Multi-Drug Urine Test Panel (FDA 510(k) Clearance)

Also includes:
BioSieveTM Multi-Drug Urine Test Panel Rx

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233062 · Vivachek Biotech (Hangzhou) Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2023
Decision
37d
Days
Class 2
Risk

K233062 is an FDA 510(k) clearance for the BioSieveTM Multi-Drug Urine Test Panel. Classified as Test, Amphetamine, Over The Counter (product code NFT), Class II - Special Controls.

Submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on November 2, 2023 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vivachek Biotech (Hangzhou) Co., Ltd. devices

Submission Details

510(k) Number K233062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2023
Decision Date November 02, 2023
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 87d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFT Test, Amphetamine, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - NFT Test, Amphetamine, Over The Counter

All 28
Devices cleared under the same product code (NFT) and FDA review panel - the closest regulatory comparables to K233062.
SAFElife T-Dip Multi-Drug Urine Test Panel
K260065 · Guangzhou Wondfo Biotech Co., Ltd. · Apr 2026
Webest Multi-Drug Urine Cup
K260355 · WEBEST Biotech,, LLC · Mar 2026
SAFElife T-Cup Multi-Drug Urine Test Cup
K252550 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2025
VINScreen Urine Drug Test Cup
K252867 · Advin Biotech, Inc. · Oct 2025
Wisdiag Multi-Drug Urine Test Cup
K252554 · Vivachek Biotech (Hangzhou) Co., Ltd. · Sep 2025
CLUNGENE Multi-Drug Test Easy Cup
K252118 · Hangzhou Clongene Biotech Co., Ltd. · Aug 2025