Cleared Traditional

K000928 - QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL...

K000928 is the FDA 510(k) clearance for QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL... by Oxoid , Ltd.. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K000928 · Oxoid , Ltd. · Microbiology device
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May 2000
Decision
54d
Days
Class 2
Risk

K000928 is an FDA 510(k) clearance for the QUINUPRISTIN/DALFOPRISTIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on May 15, 2000 after a review of 54 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 Oxoid , Ltd. devices

Submission Details

510(k) Number K000928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2000
Decision Date May 15, 2000
Days to Decision 54 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
48d faster than avg
Panel avg: 102d · This submission: 54d
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 K000928.
HARDYDISK CEFOPERAZONE, 75 MCG
K001489 · Hardy Diagnostics · Jun 2000
HARDYDISK CEFONICID, 30 MCG
K001490 · Hardy Diagnostics · Jun 2000
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K000930 · Oxoid , Ltd. · May 2000
MOXIFLOXACIN, 5 UG, BBL SENSI-DISC
K000762 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 2000
HARDYDISK, CEPHALOTHIN 30MCG
K000526 · Hardy Diagnostics · Apr 2000
GATIFLOXACIN, 5 UG, BBL SENSI-DISC
K000829 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 2000