Cleared Traditional

CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS (K893754) - FDA 510(k) Clearance

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

K893754 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jul 1989
Decision
56d
Days
Class 2
Risk

K893754 is an FDA 510(k) clearance for the CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 56 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 K893754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1989
Decision Date July 14, 1989
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 102d · This submission: 56d
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 K893754.
OFLOXACIN, 5 MCG SENSI-DISC
K910506 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1991
CEFMATZOLE 30 MCG SENSI DISC
K895679 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
SPECTINOMYCIN 100 MCG SENSI-DISC
K891772 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989
CIPROFLOXACIN 5 MCG SENSI-DISC
K874425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1987
AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC
K872783 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987
NORFLOXACIN 10 MCG SENSI DISC
K864756 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987