Cleared Traditional

NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK (K864848) - FDA 510(k) Clearance

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

K864848 · Organon Teknika Corp. · Microbiology device
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Mar 1987
Decision
97d
Days
Class 2
Risk

K864848 is an FDA 510(k) clearance for the NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on March 17, 1987 after a review of 97 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Organon Teknika Corp. devices

Submission Details

510(k) Number K864848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1986
Decision Date March 17, 1987
Days to Decision 97 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
5d faster than avg
Panel avg: 102d · This submission: 97d
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 99
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K864848.
AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC
K872783 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1987
TICARCILLIN/CLVULINIC ACID 85 MCG SUSCEPTIBILITY D
K871674 · Organon Teknika Corp. · May 1987
NORFLOXACIN 10 MCG SENSI DISC
K864756 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
AZTREONAM 30 MCG SUSCEPTIBILITY DISK
K870870 · Organon Teknika Corp. · Mar 1987
AZTREONAM 30 MCG. SENSI-DISC
K865034 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1987
CEFOTETAN 30 MCG ANTIMICROBIAL SUSCEPTIBILITY DISK
K860895 · Organon Teknika Corp. · Apr 1986