K181289 is an FDA 510(k) clearance for the Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System. This device is classified as a Respiratory Virus Panel Nucleic Acid Assay System (Class II - Special Controls, product code OCC).
Submitted by Cepheid (Sunnyvale, US). The FDA issued a Cleared decision on August 15, 2018, 91 days after receiving the submission on May 16, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3980. A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus..
| 510(k) Number | K181289 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2018 |
| Decision Date | August 15, 2018 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | OCC — Respiratory Virus Panel Nucleic Acid Assay System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3980 |
| Definition | A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection And Identification Of A Specific Viral Nucleic Acid From Individuals Exhibiting Signs And Symptoms Of Respiratory Infection Aids In The Diagnosis Of Respiratory Viral Infection When Used In Conjunction With Other Clinical And Laboratory Findings. The Device Is Intended For Detection And Identification Of A Combination Of The Following Viruses: Influenza A And Influenza B, Influenza A Subtype H1 And Influenza A Subtype H3, Respiratory Syncytial Virus Subtype A And Respiratory Syncytial Virus Subtype B, Parainfluenza 1, Parainfluenza 2, And Parainfluenza 3 Virus, Human Metapneumovirus, Rhinovirus, And Adenovirus. |