Cleared Traditional

K093604 - ETEST MOXIFLOXACIN 0.002-32 UG/ML

K093604 is an FDA 510(k) clearance for ETEST MOXIFLOXACIN 0.002-32 UG/ML, manufactured by Ab Biomerieux. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 278-day FDA review.

K093604 · Ab Biomerieux · Microbiology device
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Aug 2010
Decision
278d
Days
Class 2
Risk

K093604 is an FDA 510(k) clearance for the ETEST MOXIFLOXACIN 0.002-32 UG/ML. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biomerieux (Solna, SE). The FDA issued a Cleared decision on August 25, 2010 after a review of 278 days - an extended review 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: 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 Biomerieux devices

FDA 510(k) Submission Details - K093604

510(k) Number K093604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2009
Decision Date August 25, 2010
Days to Decision 278 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
176d slower than avg
Panel avg: 102d · This submission: 278d
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 407
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K093604.
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