Cleared Traditional

K083606 - SENSITITRE 18-24 HOUR SUSECEPTIBILITY P...

K083606 is the FDA 510(k) clearance for SENSITITRE 18-24 HOUR SUSECEPTIBILITY P... by Trek Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K083606 · Trek Diagnostic Systems, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
109d
Days
Class 2
Risk

K083606 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 24, 2009 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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 Trek Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K083606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2008
Decision Date March 24, 2009
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 102d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JWY Manual Antimicrobial Susceptibility Test Systems

All 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K083606.
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · Thermo Fisher Scientific · Feb 2014
ETEST CEFTAROLINE
K121002 · bioMerieux, Inc. · Oct 2012
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
K093865 · Trek Diagnostic Systems, Inc. · Feb 2010
SENSITITRE VIZION
K081520 · Trek Diagnostic Systems, Inc. · Oct 2008
ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT 0.002-32 UG/ML
K081325 · Ab Biodisk · Jul 2008
SENSITITRE 18 - 24 HOUR SUSCEPTIBILITY PLATE
K073653 · Trek Diagnostic Systems, Inc. · Mar 2008