Cleared Traditional

K152285 - illumigene Pertussis DNA Amplification Assay

K152285 is an FDA 510(k) clearance for illumigene Pertussis DNA Amplification ..., manufactured by Meridian Bioscience, Inc.. The device is a Class 2 Microbiology device with product code OZZ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K152285 · Meridian Bioscience, Inc. · Microbiology device
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Nov 2015
Decision
90d
Days
Class 2
Risk

K152285 is an FDA 510(k) clearance for the illumigene Pertussis DNA Amplification Assay. Classified as Bordetella Pertussis Dna Assay System (product code OZZ), Class II - Special Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on November 10, 2015 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - 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 Meridian Bioscience, Inc. devices

FDA 510(k) Submission Details - K152285

510(k) Number K152285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2015
Decision Date November 10, 2015
Days to Decision 90 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
12d faster than avg
Panel avg: 102d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OZZ Device Classification - Class 2, Special Controls

Product Code OZZ Bordetella Pertussis Dna Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Qualitative In Vitro Diagnostic Assay Intended To Detect Bordetella Pertussis Dna Extracted From Human Respiratory Specimens. Detection Of Bordetella Pertussis Dna Aids In The Diagnosis Of Bordetella Pertussis Respiratory Infection In Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infection.
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 - OZZ Bordetella Pertussis Dna Assay System

All 7
Devices cleared under the same product code (OZZ) and FDA review panel - the closest regulatory comparables to K152285.
Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
K173498 · Diasorin Molecular, LLC · Aug 2018
Solana Bordetella Complete Assay
K181029 · Quidel Corporation · Jul 2018
Great Basin Bordetella Direct Test
K170284 · Great Basin Scientific, Inc. · Mar 2017
AmpliVue Bordetella Assay
K143206 · Quidel Corporation · Dec 2014
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
K133673 · Meridian Bioscience, Inc. · Mar 2014