Cleared Traditional

K112276 - VIZION

K112276 is an FDA 510(k) clearance for VIZION, manufactured by Trek Diagnostic Systems. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K112276

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.

JWY Device Classification - Class 2, Special Controls

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 404
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 18-24 HR SUSCEPTIBILITY PLATES
K111615 · Trek Diagnostic Systems · Nov 2011
SENSITITRE (R) HP MIC SUSCEPTIBILITY PLATE WITH CEFAROLINE (0.004-8UG/ML) AND THE SENSITITRE (R) 18-24 HOUR MIC SUSCE...
K111429 · Trek Diagnostic Systems, Ltd. · Aug 2011
ETEST TELAVANCIN IN 0.002-32 UG/ML AND 0.016-256 UG/ML
K102535 · Biomerieux S.A. · May 2011