FilmArray Pneumonia Panel plus
FDA 510(k) clearance K181324 · decided 2018-11-15
Clearance details
- K-number
- K181324
- Device name
- FilmArray Pneumonia Panel plus
- Applicant
- Biofire Diagnostics, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-05-18
- Decision date
- 2018-11-15
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- QDS
- Device class
- 2
- Regulation number
- 866.4001
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus) (K243222) | Biofire Diagnostics, LLC (Biomerieux) | 2024-11-06 |
| FilmArray Pneumonia Panel plus (K222601) | Biofire Diagnostics, LLC | 2022-10-27 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 recall (Z-1518-2025) | BioFire Diagnostics, LLC | 2025-04-04 |
| FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (3 recall (Z-0993-2024) | BioFire Diagnostics, LLC | 2024-02-06 |