Cleared Special

K081520 - SENSITITRE VIZION

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

K081520 · Trek Diagnostic Systems, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K081520

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.

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 440
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K081520.
SENSITITRE 18-24HR SUSCEPTIBILITY PLATES
K093865 · Trek Diagnostic Systems, Inc. · Feb 2010
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K092445 · Trek Diagnostic Systems, Ltd. · Dec 2009
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES
K083606 · Trek Diagnostic Systems, Inc. · Mar 2009
MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN
K081182 · Siemens · Aug 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
K081520 · SENSITITRE VIZION
Download PDF FDA Summary Trek Diagnostic Syste…