Cleared Traditional

ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT

K123423 · Meridian Bioscience, Inc. · Microbiology
Jun 2013
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K123423 is an FDA 510(k) clearance for the ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT, 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 5, 2013, 211 days after receiving the submission on November 6, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3980.

Submission Details

510(k) Number K123423 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2012
Decision Date June 05, 2013
Days to Decision 211 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.