Cleared Traditional

Copan Universal Transport Medium (UTM-RT) System (K232357) - FDA 510(k) Clearance

Class I Microbiology device.

K232357 · Copan Italia Spa · Microbiology device
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Apr 2024
Decision
262d
Days
Class 1
Risk

K232357 is an FDA 510(k) clearance for the Copan Universal Transport Medium (UTM-RT) System. Classified as Culture Media, Non-propagating Transport (product code JSM), Class I - General Controls.

Submitted by Copan Italia Spa (Brescia, IT). The FDA issued a Cleared decision on April 25, 2024 after a review of 262 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 Copan Italia Spa devices

Submission Details

510(k) Number K232357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 07, 2023
Decision Date April 25, 2024
Days to Decision 262 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
160d slower than avg
Panel avg: 102d · This submission: 262d
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 36
Devices cleared under the same product code (JSM) and FDA review panel - the closest regulatory comparables to K232357.
Viral Transport Medium
K233534 · Hardy Diagnostics · Aug 2024
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Viral Transport Media (VTM)
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Azer Scientific Universal Transport Medium
K202531 · Azer Scientific, Inc. · Apr 2024
ARX Viral Transport Media Collection and Transport System
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KaiBiLi Extended ViralTrans
K231027 · Hangzhou Genesis Biodetection & Biocontrol Co., Ltd. · Dec 2023