Cleared Traditional

K003834 - SENSITITRE SUSCEPTIBILITY PLATES-ADDITI...

K003834 is the FDA 510(k) clearance for SENSITITRE SUSCEPTIBILITY PLATES-ADDITI... by Trek Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K003834 · Trek Diagnostic Systems, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
Feb 2001
Decision
73d
Days
Class 2
Risk

K003834 is an FDA 510(k) clearance for the SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Westlake, US). The FDA issued a Cleared decision on February 23, 2001 after a review of 73 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Trek Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K003834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2000
Decision Date February 23, 2001
Days to Decision 73 days
Submission Type Traditional
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
29d faster than avg
Panel avg: 102d · This submission: 73d
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 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K003834.
ETEST MEROPENEM
K010363 · Ab Biodisk · Apr 2001
SUSCEPTIBILITY TEST PANEL
K004045 · Trek Diagnostic Systems, Inc. · Mar 2001
SENSITITRE SUSCEPTIBILITY PLATES-ADDITIONAL ANTIMICROBICS
K003868 · Trek Diagnostic Systems, Inc. · Feb 2001
PASCO MIC AND MIC/ID PANELS
K001953 · Pasco Laboratories, Inc. · Aug 2000
MODIFICATION TO PASCO MIC AND MIC/ID PANELS
K001887 · Pasco Laboratories, Inc. · Aug 2000
ETEST ESBL CT/CTL STRIP
K001547 · Ab Biodisk · Aug 2000