K222601 is an FDA 510(k) clearance for the FilmArray Pneumonia Panel plus. This device is classified as a Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System (Class II - Special Controls, product code QDS).
Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on October 27, 2022, 59 days after receiving the submission on August 29, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.4001. A Middle East Respiratory Syndrome Coronavirus (mers-cov) And Common Respiratory Pathogens Qualitative, Semi-quantitative Or Quantitative Multiplex Nucleic Acid Detection System Is An In Vitro Diagnostic Test For The Detection, Identification, And Quantification Of Mers-cov And Common Respiratory Pathogens Associated Nucleic Acids In Human Clinical Specimens. The Test Is Indicated For Individuals Meeting Specific Mers-cov Clinical And/or Epidemiological Criteria. It Aids In The Differential Diagnosis Of Mers-cov Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data, In Accordance With The Guidelines Provided By The Appropriate Public Health Authorities..
| 510(k) Number | K222601 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 2022 |
| Decision Date | October 27, 2022 |
| Days to Decision | 59 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QDS — Mers-cov And Common Respiratory Pathogens Semi-quantitative And Quantitative Multiplex Nucleic Acid Detection System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.4001 |
| Definition | A Middle East Respiratory Syndrome Coronavirus (mers-cov) And Common Respiratory Pathogens Qualitative, Semi-quantitative Or Quantitative Multiplex Nucleic Acid Detection System Is An In Vitro Diagnostic Test For The Detection, Identification, And Quantification Of Mers-cov And Common Respiratory Pathogens Associated Nucleic Acids In Human Clinical Specimens. The Test Is Indicated For Individuals Meeting Specific Mers-cov Clinical And/or Epidemiological Criteria. It Aids In The Differential Diagnosis Of Mers-cov Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data, In Accordance With The Guidelines Provided By The Appropriate Public Health Authorities. |