Cleared Traditional

K984608 - GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY...

K984608 is the FDA 510(k) clearance for GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY... by Oxoid , Ltd.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K984608 · Oxoid , Ltd. · Microbiology device
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Mar 1999
Decision
71d
Days
Class 2
Risk

K984608 is an FDA 510(k) clearance for the GENTAMICIN 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 March 9, 1999 after a review of 71 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

Submission Details

510(k) Number K984608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 1998
Decision Date March 09, 1999
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 282
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K984608.
PASCO MIC AND MIC/ID PANELS, LEVOFLOXACIN
K992297 · Pasco Laboratories, Inc. · Sep 1999
PASCO MIC AND MIC/ID PANELS (CEFUROXIME)
K992076 · Pasco Laboratories, Inc. · Aug 1999
TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984513 · Oxoid , Ltd. · Apr 1999
NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984036 · Oxoid , Ltd. · Jan 1999
MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K983718 · Oxoid , Ltd. · Dec 1998
CEFPROZIL ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K982517 · Oxoid , Ltd. · Sep 1998