K230404 is an FDA 510(k) clearance for the BIOFIRE FILMARRAY Gastrointestinal (GI) Panel. This device is classified as a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System (Class II - Special Controls, product code PCH).
Submitted by Biofire Diagnostics, LLC (Salt Lake City, US). The FDA issued a Cleared decision on March 16, 2023, 29 days after receiving the submission on February 15, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3990. A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation And Other Laboratory Findings..
| 510(k) Number | K230404 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 15, 2023 |
| Decision Date | March 16, 2023 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-based Assay System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3990 |
| Definition | A Gastrointestinal Pathogen Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Gastrointestinal Microbial Nucleic Acids Extracted From Human Stool Specimens. The Detection And Identification Of A Specific Gastrointestinal Microbial Nucleic Acid From Individuals Exhibiting Signs And/or Symptoms Of Gastrointestinal Infection Aids In The Diagnosis Of Gastrointestinal Infection When Used In Conjunction With Clinical Evaluation And Other Laboratory Findings. |