Cleared Traditional

K083606 - SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES

K083606 is an FDA 510(k) clearance for SENSITITRE 18-24 HOUR SUSECEPTIBILITY P..., manufactured by Trek Diagnostic Systems, Inc.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K083606 · Trek Diagnostic Systems, Inc. · Microbiology device
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Mar 2009
Decision
109d
Days
Class 2
Risk

K083606 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES. 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 March 24, 2009 after a review of 109 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, Inc. devices

FDA 510(k) Submission Details - K083606

510(k) Number K083606 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2008
Decision Date March 24, 2009
Days to Decision 109 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 102d · This submission: 109d
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
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