Cleared Traditional

K233534 - Viral Transport Medium (FDA 510(k) Clearance)

Class I Microbiology device.

K233534 · Hardy Diagnostics · Microbiology device
Download Printable Device Report (PDF)
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

Submission Details

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.

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 110
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K233534.
Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device
K242976 · Medical Wire & Equipment Company (Bath), Ltd. · Nov 2025
Babio® Virus Transport Kit (Non-inactivating)
K250205 · Jinan Babio Biotechnology Co., Ltd. · Sep 2025
AllTest Viral Transport Medium
K242576 · Hangzhou AllTest Biotech Co., Ltd. · Apr 2025
UriSponge™
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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