510(k) K152285
K152285 is an FDA 510(k) premarket notification submitted by Meridian Bioscience, Inc. for the device "illumigene Pertussis DNA Amplification Assay". The FDA issued a decision of Substantially Equivalent on November 10, 2015. The device falls under product code OZZ (Bordetella Pertussis Dna Assay System), a Class II device regulated under 21 CFR 866.3980. Meridian Bioscience, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 2015
- Date Received
- August 12, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bordetella Pertussis 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 Bordetella pertussis DNA extracted from human respiratory specimens. Detection of Bordetella pertussis DNA aids in the diagnosis of Bordetella pertussis respiratory infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infection.