Cleared Traditional

K946364 - E TEST FOR OFLOXACIN

K946364 is the FDA 510(k) clearance for E TEST FOR OFLOXACIN by Ab Biodisk. It is a Class 2 Microbiology device (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

Submission Details

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.

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 K946364.
DRIED GRAM-POSITIVE MIC/COMBO PANELS
K934458 · Baxter Diagnostics, Inc. · Jul 1995
SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
K936305 · Radiometer America, Inc. · Jul 1995
TICARCILLIN/CLAVULANIC ACID 2
K951879 · Ab Biodisk · Jul 1995
DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI
K950817 · Baxter Diagnostics, Inc. · Apr 1995
ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS
K945433 · Ab Biodisk · Mar 1995
SENSITITRE SUSCEPTIBILITY ENTEROCOCCAL VANCO AMP
K944753 · Radiometer America, Inc. · Feb 1995