Parainfluenza Multiplex Nucleic Acid Assay
The Parainfluenza Multiplex Nucleic Acid Assay (product code OOU) is a Class 2 in vitro diagnostic device regulated under 21 CFR 866.3980 in the Microbiology specialty (MI), cleared via 510(k). It is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza virus types 1, 2, 3, and 4 nucleic acids from human respiratory specimens or viral culture, aiding in the diagnosis of respiratory tract parainfluenza infections when used alongside other clinical and laboratory findings. The device is not an implant or life-sustaining.
Basic Information
- Product Code
- OOU
- Device Class
- FDA class 2
- Regulation Number
- 866.3980
- Medical Specialty
- Microbiology
- Review Panel
- MI
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K172282 | Panther Fusion Paraflu Assay | Oct 23, 2017 | Substantially Equivalent | Hologic, Inc. |
| K153223 | ProParaFlu+ Assay | Dec 09, 2015 | Substantially Equivalent | HOLOGIC, INC. |
| K141927 | LYRA PARAINFLUENZA VIRUS ASSAY | Oct 09, 2014 | Substantially Equivalent | QUIDEL CORPORATION |
| K132238 | PROPARAFLU+ ASSAY | Aug 26, 2013 | Substantially Equivalent | GEN-PROBE PRODESSE, INC. |
| K091053 | PROPARAFLU+ASSAY | Nov 20, 2009 | Substantially Equivalent | PRODESSE, INC. |
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.