Cleared Traditional

GATIFLOXACIN, 5 UG, BBL SENSI-DISC (K000829) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K000829 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
30d
Days
Class 2
Risk

K000829 is an FDA 510(k) clearance for the GATIFLOXACIN, 5 UG, BBL SENSI-DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Sparks, US). The FDA issued a Cleared decision on April 13, 2000 after a review of 30 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K000829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2000
Decision Date April 13, 2000
Days to Decision 30 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
72d faster than avg
Panel avg: 102d · This submission: 30d
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 78
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K000829.
GEMIFLOXACIN, 5UG BBL SENSI-DISC
K050062 · Becton, Dickinson & CO · Feb 2005
ERTAPENEM 10UG BBL SENSI-DISC
K020842 · Becton, Dickinson & CO · May 2002
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
K000762 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 2000
SYNERCID, 15 UG, BBL SENSI-DISC
K993186 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1999
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1996
CEFPODOXIME 10 MCG, SENSI DISC
K924797 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1992