510(k) K141927
K141927 is an FDA 510(k) premarket notification submitted by Quidel Corporation for the device "LYRA PARAINFLUENZA VIRUS ASSAY". The FDA issued a decision of Substantially Equivalent on October 9, 2014. The device falls under product code OOU (Parainfluenza Multiplex Nucleic Acid Assay), a Class II device regulated under 21 CFR 866.3980. Quidel Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2014
- Date Received
- July 16, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Parainfluenza Multiplex Nucleic Acid Assay
- Device Class
- Class II
- Regulation Number
- 866.3980
- Review Panel
- MI
- Submission Type
A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings.