Cleared Traditional

K974394 - ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY T...

K974394 is an FDA 510(k) clearance for ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY T..., manufactured by Oxoid , Ltd.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K974394 · Oxoid , Ltd. · Microbiology device
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Jan 1998
Decision
55d
Days
Class 2
Risk

K974394 is an FDA 510(k) clearance for the ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on January 14, 1998 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Oxoid , Ltd. devices

FDA 510(k) Submission Details - K974394

510(k) Number K974394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 1997
Decision Date January 14, 1998
Days to Decision 55 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
47d faster than avg
Panel avg: 102d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTN Device Classification - Class 2, Special Controls

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
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 - JTN Susceptibility Test Discs, Antimicrobial

All 313
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K974394.
TROVAFLOXACIN 10G, SENSI-DISC
K980683 · Becton Dickinson Microbiology Systems · May 1998
GREPAFLOXACIN, 5 MG, SENSI-DISC
K974578 · Becton Dickinson Microbiology Systems · Feb 1998
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971636 · Oxoid , Ltd. · Jan 1998
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971637 · Oxoid , Ltd. · Dec 1997
CEFMETAZOLE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973479 · Oxoid , Ltd. · Dec 1997
LOMEFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K973488 · Oxoid , Ltd. · Oct 1997