Cleared Traditional

K000596 - ETEST GATIFLOXACIN

K000596 is an FDA 510(k) clearance for ETEST GATIFLOXACIN, manufactured by Ab Biodisk. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K000596 · Ab Biodisk · Microbiology device
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May 2000
Decision
90d
Days
Class 2
Risk

K000596 is an FDA 510(k) clearance for the ETEST GATIFLOXACIN. 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 22, 2000 after a review of 90 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

FDA 510(k) Submission Details - K000596

510(k) Number K000596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2000
Decision Date May 22, 2000
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
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
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K000596.
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
SENSITITRE 18-24 HOURS SUSCEPTIBILITY PLATES (GATIFLOXACIN)
K001035 · Trek Diagnostic Systems, Inc. · May 2000
ETEST MOXIFLOXACIN
K000298 · Ab Biodisk · May 2000
MICROSTREP PLUS PANEL, LEVOFLOXACIN
K983943 · Dade Microscan, Inc. · Feb 2000
MICROSTREP PLUS PANEL, VANCOMYCIN
K983953 · Dade Microscan, Inc. · Jan 2000