Cleared Traditional

K902082 - ZEFAZONE SUSCEPTIBILITY TEST DISKS

K902082 is the FDA 510(k) clearance for ZEFAZONE SUSCEPTIBILITY TEST DISKS by Difco Laboratories, Inc.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K902082 · Difco Laboratories, Inc. · Microbiology device
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Jun 1990
Decision
38d
Days
Class 2
Risk

K902082 is an FDA 510(k) clearance for the ZEFAZONE SUSCEPTIBILITY TEST DISKS. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on June 15, 1990 after a review of 38 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 Difco Laboratories, Inc. devices

Submission Details

510(k) Number K902082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1990
Decision Date June 15, 1990
Days to Decision 38 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
64d faster than avg
Panel avg: 102d · This submission: 38d
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 K902082.
CLARITHROMYCIN 15MCG SENSI DISC
K920131 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1992
OFLOXACIN, 5 MCG SENSI-DISC
K910506 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1991
FLOXIN SUSCEPTIBILITY TEST DISKS
K910412 · Difco Laboratories, Inc. · Feb 1991
CEFIXIME 5 MCG SUSCEPTIBILITY DISK
K900344 · Organon Teknika Corp. · Feb 1990
CEFMATZOLE 30 MCG SENSI DISC
K895679 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
ANTIMICROBIAL SUSCEPTIBILITY DISK
K895392 · Organon Teknika Corp. · Oct 1989