Cleared Traditional

K112276 - VIZION

K112276 is the FDA 510(k) clearance for VIZION by Trek Diagnostic Systems. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K112276 · Trek Diagnostic Systems · Microbiology device
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Nov 2011
Decision
99d
Days
Class 2
Risk

K112276 is an FDA 510(k) clearance for the VIZION. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Trek Diagnostic Systems (Cleveland, US). The FDA issued a Cleared decision on November 16, 2011 after a review of 99 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 devices

Submission Details

510(k) Number K112276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2011
Decision Date November 16, 2011
Days to Decision 99 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
3d faster than avg
Panel avg: 102d · This submission: 99d
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 K112276.
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