Cleared Traditional

K001780 - COPAN VIRAL TRANSYSTEM

K001780 is an FDA 510(k) clearance for COPAN VIRAL TRANSYSTEM, 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 413-day FDA review.

K001780 · Copan Diagnostics, Inc. · Microbiology device
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Jul 2001
Decision
413d
Days
Class 1
Risk

K001780 is an FDA 510(k) clearance for the COPAN VIRAL TRANSYSTEM. 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 July 31, 2001 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Copan Diagnostics, Inc. devices

FDA 510(k) Submission Details - K001780

510(k) Number K001780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2000
Decision Date July 31, 2001
Days to Decision 413 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
311d slower than avg
Panel avg: 102d · This submission: 413d
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 69
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