Cleared Traditional

K121039 - COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM

K121039 is an FDA 510(k) clearance for COPAN MSWAB COLLECTION, manufactured by Copan Flock Technologies. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K121039 · Copan Flock Technologies · Microbiology device
Download Printable Device Report (PDF)
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May 2012
Decision
50d
Days
Class 1
Risk

K121039 is an FDA 510(k) clearance for the COPAN MSWAB COLLECTION, TRANSPORT AND PRESERVATION SYSTEM. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Copan Flock Technologies (North Attleboro, US). The FDA issued a Cleared decision on May 25, 2012 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2900 - 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.

View all Copan Flock Technologies devices

FDA 510(k) Submission Details - K121039

510(k) Number K121039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2012
Decision Date May 25, 2012
Days to Decision 50 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
52d faster than avg
Panel avg: 102d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

JTW Device Classification - Class 1, General Controls

Product Code JTW System, Transport, Aerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTW System, Transport, Aerobic

All 29
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K121039.
COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM
K061301 · Copan Diagnostics, Inc. · Jun 2006
GEN-PROBE APTIMA COMBO 2 ASSAY
K022874 · Gen-Probe, Inc. · Sep 2002
COPAN EASY-SWAB COLLECTION AND TRANSPORT SYSTEM
K993161 · Copan Diagnostics, Inc. · Nov 1999
SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
K983244 · Trek Diagnostic Systems, Inc. · Nov 1998
CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)
K961148 · Difco Laboratories, Inc. · Apr 1996
CULTURESWAB TRANSPORT SYSTEM
K934894 · Difco Laboratories, Inc. · Feb 1994