Cleared Traditional

K011384 - HARDYDISK NOVOBIOCIN

K011384 is the FDA 510(k) clearance for HARDYDISK NOVOBIOCIN by Hardy Diagnostics. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K011384 · Hardy Diagnostics · Microbiology device
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Jun 2001
Decision
37d
Days
Class 2
Risk

K011384 is an FDA 510(k) clearance for the HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on June 13, 2001 after a review of 37 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 Hardy Diagnostics devices

Submission Details

510(k) Number K011384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2001
Decision Date June 13, 2001
Days to Decision 37 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 102d · This submission: 37d
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 K011384.
GEMIFLOXACIN, 5UG BBL SENSI-DISC
K050062 · Becton, Dickinson & CO · Feb 2005
DAPTOMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K042157 · Oxoid , Ltd. · Sep 2004
ERTAPENEM 10UG BBL SENSI-DISC
K020842 · Becton, Dickinson & CO · May 2002
HARDKYDISK NEOMYCIN, 30 MCG
K011385 · Hardy Diagnostics · May 2001
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
K011086 · Hardy Diagnostics · Apr 2001
MOXIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K010536 · Oxoid , Ltd. · Apr 2001