Cleared Traditional

K111429 - SENSITITRE HP MIC SUSCEPTIBILITY PLATE ...

K111429 is the FDA 510(k) clearance for SENSITITRE HP MIC SUSCEPTIBILITY PLATE ... by Trek Diagnostic Systems, Ltd.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K111429 · Trek Diagnostic Systems, Ltd. · Microbiology device
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Aug 2011
Decision
87d
Days
Class 2
Risk

K111429 is an FDA 510(k) clearance for the SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND.... Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Ltd. (Cleveland, US). The FDA issued a Cleared decision on August 18, 2011 after a review of 87 days - a notably fast clearance cycle.

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: 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 Trek Diagnostic Systems, Ltd. devices

Submission Details

510(k) Number K111429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2011
Decision Date August 18, 2011
Days to Decision 87 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 102d · This submission: 87d
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 361
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K111429.
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
K140985 · Thermo Fisher Scientific · Jun 2014
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 18-24 HOUR SUSECEPTIBILITY PLATES
K083606 · Trek Diagnostic Systems, Inc. · Mar 2009
SENSITITRE VIZION
K081520 · Trek Diagnostic Systems, Inc. · Oct 2008