Cleared Traditional

BioSci™ Disposable Virus Sampling Tubes (K230035) - FDA 510(k) Clearance

Class I Microbiology device.

K230035 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Microbiology device
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Apr 2023
Decision
90d
Days
Class 1
Risk

K230035 is an FDA 510(k) clearance for the BioSci™ Disposable Virus Sampling Tubes. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Shenzhen Dakewe Bio-Engineering Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on April 5, 2023 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - the FDA microbiology 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Dakewe Bio-Engineering Co., Ltd. devices

Submission Details

510(k) Number K230035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2023
Decision Date April 05, 2023
Days to Decision 90 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSM Culture Media, Non-propagating Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSM Culture Media, Non-propagating Transport

All 38
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K230035.
ARX Viral Transport Media Collection and Transport System
K231843 · Arx Sciences, Inc. · Mar 2024
KaiBiLi Extended ViralTrans
K231027 · Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. · Dec 2023
MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System
K212743 · Medschenker, Inc. · May 2023
Copan FecalSwab Collection, Transport and Preservation System
K220052 · Copan Italia Spa · Dec 2022
Disposable Urine Collection Tube
K220739 · Zhejiang Gongdong Medical Technology Co., Ltd. · Nov 2022
iClean Viral Transport System (VTM-RT kit)
K212856 · Huachenyang (Shenzhen) Technology Co. , Ltd. · Aug 2022