Cleared Traditional

K061301 - COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM

K061301 is an FDA 510(k) clearance for COPAN LIQUID AMIES ELUTION SWAB (ESWAB)..., manufactured by Copan Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code JTW cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K061301 · Copan Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
44d
Days
Class 1
Risk

K061301 is an FDA 510(k) clearance for the COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM. Classified as System, Transport, Aerobic (product code JTW), Class I - General Controls.

Submitted by Copan Diagnostics, Inc. (North Attleboro, US). The FDA issued a Cleared decision on June 23, 2006 after a review of 44 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 Diagnostics, Inc. devices

FDA 510(k) Submission Details - K061301

510(k) Number K061301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 2006
Decision Date June 23, 2006
Days to Decision 44 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
58d faster than avg
Panel avg: 102d · This submission: 44d
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 28
Devices cleared under the same product code (JTW) and FDA review panel - the closest regulatory comparables to K061301.
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
MECHANICAL CHANGE IN IN-VITRO MICRO DEVICE
K882580 · Precision Dynamics Corp. · Jul 1988