K212727 is an FDA 510(k) clearance for the FilmArray Pneumonia Panel. This device is classified as a Respiratory Panel (Class II - Special Controls, product code QDP).
Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on September 22, 2021, 26 days after receiving the submission on August 27, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3985. The Panel Is A Multiplexed Nucleic Acid Test Intended For Use With Systems For The Simultaneous Detection And Identification Of Multiple Respiratory Viral And Bacterial Nucleic Acids, As Well As Select Antimicrobial Resistance Genes, In Sputum-like Specimens (induced Or Expectorated Sputum, Or Endotracheal Aspirates) Or Bronchoalveolar Lavage (bal)-like Specimens (bal Or Mini-bal) Obtained From Individuals Suspected Of Lower Respiratory Tract Infection..
| 510(k) Number | K212727 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 2021 |
| Decision Date | September 22, 2021 |
| Days to Decision | 26 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | QDP — Respiratory Panel |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3985 |
| Definition | The Panel Is A Multiplexed Nucleic Acid Test Intended For Use With Systems For The Simultaneous Detection And Identification Of Multiple Respiratory Viral And Bacterial Nucleic Acids, As Well As Select Antimicrobial Resistance Genes, In Sputum-like Specimens (induced Or Expectorated Sputum, Or Endotracheal Aspirates) Or Bronchoalveolar Lavage (bal)-like Specimens (bal Or Mini-bal) Obtained From Individuals Suspected Of Lower Respiratory Tract Infection. |