Cleared Traditional

K231978 - BioSieve™ Marijuana Test Panel 50 (FDA 510(k) Clearance)

Also includes:
BioSieve™ Marijuana Test Strip 50 BioSieve™ Dx Marijuana Test Strip 20 BioSieve™ Dx Marijuana Test Strip 50 BioSieve™ Dx Marijuana Test Panel 20 BioSieve™ Dx Marijuana Test Panel 50

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

K231978 · Vivachek Biotech (Hangzhou) Co., Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
59d
Days
Class 2
Risk

K231978 is an FDA 510(k) clearance for the BioSieve™ Marijuana Test Panel 50. Classified as Test, Cannabinoid, Over The Counter (product code NFW), Class II - Special Controls.

Submitted by Vivachek Biotech (Hangzhou) Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on August 31, 2023 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 K231978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2023
Decision Date August 31, 2023
Days to Decision 59 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
28d faster than avg
Panel avg: 87d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NFW Test, Cannabinoid, Over The Counter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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.