Cleared Traditional

K231843 - ARX Viral Transport Media Collection an...

K231843 is an FDA 510(k) clearance for ARX Viral Transport Media Collection an..., manufactured by Arx Sciences, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K231843 · Arx Sciences, Inc. · Microbiology device
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Mar 2024
Decision
271d
Days
Class 1
Risk

K231843 is an FDA 510(k) clearance for the ARX Viral Transport Media Collection and Transport System. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Arx Sciences, Inc. (Amherst, US). The FDA issued a Cleared decision on March 19, 2024 after a review of 271 days - an extended review cycle.

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 Arx Sciences, Inc. devices

FDA 510(k) Submission Details - K231843

510(k) Number K231843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2023
Decision Date March 19, 2024
Days to Decision 271 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
169d slower than avg
Panel avg: 102d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

JSM Device Classification - Class 1, General Controls

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 58
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K231843.
Viral Transport Media (VTM)
K232454 · Alb Luz · May 2024
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K232357 · Copan Italia Spa · Apr 2024
Azer Scientific Universal Transport Medium
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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
BioSci™ Disposable Virus Sampling Tubes
K230035 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Apr 2023