Cleared Traditional

REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK (K970830) - FDA 510(k) Clearance

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

K970830 · Remel, Inc. · Microbiology device
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Apr 1997
Decision
26d
Days
Class 2
Risk

K970830 is an FDA 510(k) clearance for the REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on April 2, 1997 after a review of 26 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 Remel, Inc. devices

Submission Details

510(k) Number K970830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1997
Decision Date April 02, 1997
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 102d · This submission: 26d
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 210
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K970830.
SYNERCID, 15 UG, BBL SENSI-DISC
K993186 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1999
DISPENS-O-DISC (TM) LEVOFLOXACIN
K971120 · Difco Laboratories, Inc. · Apr 1997
DISPENS-O-DISC SPARFLOXACIN
K971211 · Difco Laboratories, Inc. · Apr 1997
DISPENS-O-DISC MEROPENEM
K963508 · Difco Laboratories, Inc. · Sep 1996
CEFEPIME, 30 MCG, SENSI-DISC
K961188 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1996
REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK
K955669 · Remel Co. · Feb 1996