Product code OZX— Microbiology

“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.”

FDA has cleared 3 devices under product code OZX between 2013 and 2016, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20161 clearance
• 20151 clearance
• 20131 clearance

• Meridian Bioscience, Inc.3 clearances

• K160829 — illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10Meridian Bioscience, Inc.·2016-06-13
• K152800 — illumigene Mycoplasma DNA Amplification AssayMeridian Bioscience, Inc.·2015-10-23
• K123423 — ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KITMeridian Bioscience, Inc.·2013-06-05