Cleared Traditional

K946364 - E TEST FOR OFLOXACIN

K946364 is an FDA 510(k) clearance for E TEST FOR OFLOXACIN, 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 134-day FDA review.

K946364 · Ab Biodisk · Microbiology device
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May 1995
Decision
134d
Days
Class 2
Risk

K946364 is an FDA 510(k) clearance for the E TEST FOR OFLOXACIN. 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 2, 1995 after a review of 134 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 - K946364

510(k) Number K946364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1994
Decision Date May 02, 1995
Days to Decision 134 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
32d slower than avg
Panel avg: 102d · This submission: 134d
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 K946364.
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
K936305 · Radiometer America, Inc. · Jul 1995
TICARCILLIN/CLAVULANIC ACID 2
K951879 · Ab Biodisk · Jul 1995
ENTEROCOCCUS SCREENING MEDIUM
K951539 · Becton Dickinson Microbiology Systems · Jun 1995
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
K950817 · Baxter Diagnostics, Inc. · Apr 1995
SCEPTOR SYSTEM PANELS
K950123 · Becton Dickinson Microbiology Systems · Mar 1995
ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS
K945433 · Ab Biodisk · Mar 1995