Cleared Traditional

K233534 - Viral Transport Medium

K233534 is an FDA 510(k) clearance for Viral Transport Medium, manufactured by Hardy Diagnostics. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K233534 · Hardy Diagnostics · Microbiology device
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Optimized for regulatory review, auditing and printing
Aug 2024
Decision
273d
Days
Class 1
Risk

K233534 is an FDA 510(k) clearance for the Viral Transport Medium. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on August 2, 2024 after a review of 273 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 Hardy Diagnostics devices

FDA 510(k) Submission Details - K233534

510(k) Number K233534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2023
Decision Date August 02, 2024
Days to Decision 273 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
171d slower than avg
Panel avg: 102d · This submission: 273d
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 77
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K233534.
UriSponge™
K232565 · Copan Italia Spa · Oct 2024
Ensol EnTM Specimen Collection and Transport System
K220908 · Ensol Biosciences, Inc. · Aug 2024
OmniTrans Transport System
K240235 · Shenzhen Dakewe Bio-Engineering Co., Ltd. · Aug 2024
Avantik VTM
K233449 · Hanchang Medic Co., Ltd. (Han Chang Medic) · Jul 2024
Viral Transport Media (VTM)
K232454 · Alb Luz · May 2024
Copan Universal Transport Medium (UTM-RT) System
K232357 · Copan Italia Spa · Apr 2024