Cleared Traditional

K974578 - GREPAFLOXACIN

K974578 is the FDA 510(k) clearance for GREPAFLOXACIN by Becton Dickinson Microbiology Systems. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K974578 · Becton Dickinson Microbiology Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
77d
Days
Class 2
Risk

K974578 is an FDA 510(k) clearance for the GREPAFLOXACIN, 5 MG, SENSI-DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Becton Dickinson Microbiology Systems (Sparks, US). The FDA issued a Cleared decision on February 23, 1998 after a review of 77 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 Becton Dickinson Microbiology Systems devices

Submission Details

510(k) Number K974578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1997
Decision Date February 23, 1998
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
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 287
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K974578.
CEFDINIR, 5 UG, SENSI-DISC
K981517 · Becton Dickinson Microbiology Systems · Jun 1998
PASCO MIC AND MIC/ID PANELS
K980955 · Pasco Laboratories, Inc. · May 1998
TROVAFLOXACIN 10G, SENSI-DISC
K980683 · Becton Dickinson Microbiology Systems · May 1998
RIFAMPICIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971636 · Oxoid , Ltd. · Jan 1998
ENOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K974394 · Oxoid , Ltd. · Jan 1998
COMPOUND SULPHONAMIDES ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971637 · Oxoid , Ltd. · Dec 1997