Cleared Traditional

K864848 - NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK

K864848 is an FDA 510(k) clearance for NORFLOXACIN 10 MCG SUSCEPTIBILITY DISK, manufactured by Organon Teknika Corp.. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

FDA 510(k) Submission Details - K864848

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.

JTN Device Classification - Class 2, Special Controls

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 313
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K864848.
BROTH ELUTION DISKS CLINDAMYCIN 10MCG
K870175 · Difco Laboratories, Inc. · Apr 1987
DISPENS-O-DISC BROTH ELUTION DISKS METRON. 80 MCG
K870201 · Difco Laboratories, Inc. · Apr 1987
NORFLOXACIN 10 MCG SENSI DISC
K864756 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
NORFLOXACIN 10 MCG SENSITIVITY DISKS
K870348 · Difco Laboratories, Inc. · Mar 1987
AZTREONAM 30 MCG SUSCEPTIBILITY DISK
K870870 · Organon Teknika Corp. · Mar 1987
AZTREONAM 30 MCG SENSITIVITY DISKS
K870347 · Difco Laboratories, Inc. · Mar 1987