Cleared Traditional

K000298 - ETEST MOXIFLOXACIN

K000298 is the FDA 510(k) clearance for ETEST MOXIFLOXACIN by Ab Biodisk. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K000298 · Ab Biodisk · Microbiology device
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May 2000
Decision
108d
Days
Class 2
Risk

K000298 is an FDA 510(k) clearance for the ETEST MOXIFLOXACIN. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biodisk (Solna, SE). The FDA issued a Cleared decision on May 18, 2000 after a review of 108 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 Ab Biodisk devices

Submission Details

510(k) Number K000298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2000
Decision Date May 18, 2000
Days to Decision 108 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
6d slower than avg
Panel avg: 102d · This submission: 108d
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 K000298.
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (MOXIFLOXACIN)
K001036 · Trek Diagnostic Systems, Inc. · Jun 2000
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
K001035 · Trek Diagnostic Systems, Inc. · May 2000
ETEST GATIFLOXACIN
K000596 · Ab Biodisk · May 2000
MICROSTREP PLUS PANEL, LEVOFLOXACIN
K983943 · Dade Microscan, Inc. · Feb 2000
MICROSTREP PLUS PANEL, VANCOMYCIN
K983953 · Dade Microscan, Inc. · Jan 2000
MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN
K993679 · Dade Microscan, Inc. · Jan 2000