Cleared Traditional

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

K160829 · Meridian Bioscience, Inc. · Microbiology
Jun 2016
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K160829 is an FDA 510(k) clearance for the illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10, a Mycoplasma Pneumoniae Dna Assay System (Class II — Special Controls, product code OZX), submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Cleared decision on June 13, 2016, 80 days after receiving the submission on March 25, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number K160829 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code OZX — Mycoplasma Pneumoniae Dna Assay System
Device Class Class II — 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.