Cleared Traditional

K083464 - PREMIER CAMPY

K083464 is the FDA 510(k) clearance for PREMIER CAMPY by Meridian Bioscience, Inc.. It is a Class 1 Microbiology device (product code LQP) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K083464 · Meridian Bioscience, Inc. · Microbiology device
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Jan 2009
Decision
67d
Days
Class 1
Risk

K083464 is an FDA 510(k) clearance for the PREMIER CAMPY, MODEL 618096. Classified as Campylobacter Spp. (product code LQP), Class I - General Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 30, 2009 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3110 - 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 Meridian Bioscience, Inc. devices

Submission Details

510(k) Number K083464 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2008
Decision Date January 30, 2009
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 102d · This submission: 67d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQP Campylobacter Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3110
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LQP Campylobacter Spp.

All 9
Devices cleared under the same product code (LQP) and FDA review panel - the closest regulatory comparables to K083464.
CAMPYLOBACTER QUIK CHEK
K173217 · Techlab, Inc. · Jan 2018
CAMPYLOBACTER CHEK
K173219 · Techlab, Inc. · Jan 2018
IMMUNOCARD STAT CAMPY, MODEL 751530
K090700 · Meridian Bioscience, Inc. · May 2009
MERITEC(TM)-CAMPY (JCL)
K880389 · Meridian Diagnostics, Inc. · Apr 1988
BBL CAMPYSLIDE(TM) TEST
K864027 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1986