Cleared Traditional

K160829 - illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10

K160829 is an FDA 510(k) clearance for illumigene Mycoplasma Direct DNA Amplif..., manufactured by Meridian Bioscience, Inc.. The device is a Class 2 Microbiology device with product code OZX cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K160829 · Meridian Bioscience, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
80d
Days
Class 2
Risk

K160829 is an FDA 510(k) clearance for the illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma D.... Classified as Mycoplasma Pneumoniae Dna Assay System (product code OZX), Class II - Special Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 13, 2016 after a review of 80 days - a notably fast clearance cycle.

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: 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

FDA 510(k) Submission Details - K160829

510(k) Number K160829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2016
Decision Date June 13, 2016
Days to Decision 80 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
22d faster than avg
Panel avg: 102d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

OZX Device Classification - Class 2, Special Controls

Product Code OZX Mycoplasma Pneumoniae 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 Mycoplasma Pneumoniae Dna Extracted From Human Respiratory Specimens. Detection Of Mycoplasma Pneumoniae Dna Aids In The Diagnosis Of Mycoplasma Pneumoniae 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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Microbiology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02511262 Completed Observational Industry-sponsored

Detection of Mycoplasma Pneumoniae

Clinical Trial Protocol for the Illumigene® Mycoplasma Direct Assay

471
Patients (actual)
3
Sites
Condition studied Mycoplasma Pneumoniae
Eligibility All sexes
Sponsor Meridian Bioscience, Inc. (industry)
Started 2015-08-01 Primary completion 2016-01-01
Primary outcome
Qualitative detection of Mycoplasma Pneumoniae to aid in the diagnosis of M. pneumoniae infections.
Study completed - no results published. This trial concluded in but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov