Cleared Traditional

K024353 - SENSITITRE 18-24 HOURS SUSCEPTIBILITY P...

K024353 is the FDA 510(k) clearance for SENSITITRE 18-24 HOURS SUSCEPTIBILITY P... by Trek Diagnostic Systems, Inc.. It is a Class 2 Microbiology device (product code LTT) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K024353 · Trek Diagnostic Systems, Inc. · Microbiology device
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Mar 2003
Decision
66d
Days
Class 2
Risk

K024353 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES. Classified as Panels, Test, Susceptibility, Antimicrobial (product code LTT), Class II - Special Controls.

Submitted by Trek Diagnostic Systems, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 6, 2003 after a review of 66 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 K024353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2002
Decision Date March 06, 2003
Days to Decision 66 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
36d faster than avg
Panel avg: 102d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LTT Panels, Test, Susceptibility, Antimicrobial
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 - LTT Panels, Test, Susceptibility, Antimicrobial

All 44
Devices cleared under the same product code (LTT) and FDA review panel - the closest regulatory comparables to K024353.
MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN)
K033940 · Dade Behring, Inc. · Feb 2004
PASCO MIC AND MIC/ID PANELS
K030620 · Pasco Laboratories, Inc. · Apr 2003
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K024357 · Trek Diagnostic Systems, Inc. · Mar 2003
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCIN
K021184 · Dade Microscan, Inc. · Jun 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYCIN
K021078 · Dade Microscan, Inc. · Jun 2002
MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXIME
K021111 · Dade Microscan, Inc. · Jun 2002