Cleared Traditional

K970385 - SPARFLOZACIN

K970385 is the FDA 510(k) clearance for SPARFLOZACIN by Becton Dickinson Microbiology Systems. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K970385 · Becton Dickinson Microbiology Systems · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
35d
Days
Class 2
Risk

K970385 is an FDA 510(k) clearance for the SPARFLOZACIN, 5 MCG, SENSI-DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Becton Dickinson Microbiology Systems (Cockeysville, US). The FDA issued a Cleared decision on March 10, 1997 after a review of 35 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 K970385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date March 10, 1997
Days to Decision 35 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
67d faster than avg
Panel avg: 102d · This submission: 35d
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 291
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K970385.
AZITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971635 · Oxoid , Ltd. · Jul 1997
DISPENS-O-DISC (TM) LEVOFLOXACIN
K971120 · Difco Laboratories, Inc. · Apr 1997
DISPENS-O-DISC SPARFLOXACIN
K971211 · Difco Laboratories, Inc. · Apr 1997
LEVOFLOXACIN, 5MCG, SENSI-DISC
K970212 · Becton Dickinson Microbiology Systems · Mar 1997
IMIPENEM ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964487 · Unipath , Ltd. · Feb 1997
CEFACLOR ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K964489 · Unipath , Ltd. · Feb 1997