Cleared Traditional

K001035 - SENSITITRE 18-24 HOURS SUSCEPTIBILITY P...

K001035 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 JWY) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K001035 · Trek Diagnostic Systems, Inc. · Microbiology device
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May 2000
Decision
53d
Days
Class 2
Risk

K001035 is an FDA 510(k) clearance for the SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN). 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 May 23, 2000 after a review of 53 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 K001035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2000
Decision Date May 23, 2000
Days to Decision 53 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
49d faster than avg
Panel avg: 102d · This submission: 53d
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 K001035.
PASCO MIC AND MIC/ID PANELS
K001612 · Pasco Laboratories, Inc. · Jul 2000
PASCO MIC AND MIC/ID PANELS
K001516 · Pasco Laboratories, Inc. · Jul 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
K001036 · Trek Diagnostic Systems, Inc. · Jun 2000
ETEST GATIFLOXACIN
K000596 · Ab Biodisk · May 2000
ETEST MOXIFLOXACIN
K000298 · Ab Biodisk · May 2000
MICROSTREP PLUS PANEL, LEVOFLOXACIN
K983943 · Dade Microscan, Inc. · Feb 2000