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510(k) K152800

illumigene Mycoplasma DNA Amplification Assay by Meridian Bioscience, Inc. — Product Code OZX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2015
Date Received
September 28, 2015
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mycoplasma Pneumoniae Dna Assay System
Device Class
Class II
Regulation Number
866.3980
Review Panel
MI
Submission Type

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.

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