Cleared Traditional

K984513 - TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBIL...

K984513 is the FDA 510(k) clearance for TROVAFLOXACIN ANTIMICROBIAL SUSCEPTIBIL... by Oxoid , Ltd.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K984513 · Oxoid , Ltd. · Microbiology device
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Apr 1999
Decision
105d
Days
Class 2
Risk

K984513 is an FDA 510(k) clearance for the TROVAFLOXACIN 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 April 2, 1999 after a review of 105 days - within the typical 510(k) review window.

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: 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 Oxoid , Ltd. devices

Submission Details

510(k) Number K984513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1998
Decision Date April 02, 1999
Days to Decision 105 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
3d slower than avg
Panel avg: 102d · This submission: 105d
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 K984513.
PASCO MIC AND MIC/ID PANELS (OFLOXACIN)
K992077 · Pasco Laboratories, Inc. · Sep 1999
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
GENTAMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984608 · Oxoid , Ltd. · Mar 1999
NETILMICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K984036 · Oxoid , Ltd. · Jan 1999
MEROPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K983718 · Oxoid , Ltd. · Dec 1998