Cleared Special

K081520 - SENSITITRE VIZION

K081520 is the FDA 510(k) clearance for SENSITITRE VIZION by Trek Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Special 510(k) pathway after a 147-day FDA review.

K081520 · Trek Diagnostic Systems, Inc. · Microbiology device
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Oct 2008
Decision
147d
Days
Class 2
Risk

K081520 is an FDA 510(k) clearance for the SENSITITRE VIZION. 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 October 24, 2008 after a review of 147 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Trek Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K081520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2008
Decision Date October 24, 2008
Days to Decision 147 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 102d · This submission: 147d
Pathway characteristics
Modification to existing cleared device.

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 K081520.
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
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
SENSITITRE 18-24 SUSCEPTIBILITY PLATE
K073558 · Trek Diagnostic Systems, Inc. · Mar 2008