Cleared Traditional

K042970 - COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM

K042970 is an FDA 510(k) clearance for COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-R..., manufactured by Copan Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JSM cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K042970 · Copan Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
40d
Days
Class 1
Risk

K042970 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 Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on December 7, 2004 after a review of 40 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K042970

510(k) Number K042970 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2004
Decision Date December 07, 2004
Days to Decision 40 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
62d faster than avg
Panel avg: 102d · This submission: 40d
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 107
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K042970 · COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM
Download PDF FDA Summary Copan Diagnostics, In…