FilmArray Pneumonia Panel
FDA 510(k) K212727 · Biofire Diagnostics, LLC
510(k) numberK212727
Submission
- Device name
- FilmArray Pneumonia Panel
- Applicant
- Biofire Diagnostics, LLC
Salt Lake City, UT, US - Received
- August 27, 2021
- Decision date
- September 22, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QDP – Respiratory Panel
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3985
- Specialty
- Microbiology
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…
Other 510(k)s with product code QDP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180966 | FilmArray Pneumonia PanelQDP · Traditional | Biofire Diagnostics, LLC | 11/09/2018SE |
More from Biofire Diagnostics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K243544 | BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel MiniQOF · Dual Track | 08/14/2025SE |
| K243885 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel MidPCH · Special | 01/16/2025SE |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)…PEN · Special | 12/20/2024SE |
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Traditional | 11/07/2024SE |
| K241194 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel MiniQOF · Special | 05/30/2024SE |
| K232954 | BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) PanelQOF · Dual Track | 03/26/2024SE |
| K230719 | BIOFIRE® SPOTFIRE® Respiratory (R) Panel MiniQOF · Special | 04/13/2023SE |
| K230404 | BIOFIRE FILMARRAY Gastrointestinal (GI) PanelPCH · Special | 03/16/2023SE |
| K213954 | BIOFIRE SPOTFIRE Respiratory (R) PanelQOF · Dual Track | 02/03/2023SE |
| K222601 | FilmArray Pneumonia Panel plusQDS · Special | 10/27/2022SE |
Questions and answers
When was FilmArray Pneumonia Panel cleared by the FDA?
FilmArray Pneumonia Panel (K212727) received a 510(k) decision of Substantially Equivalent on September 22, 2021, 26 days after the submission was received.
What is the product code of K212727?
The FDA product code is QDP – Respiratory Panel, a Class II (moderate risk) device regulated under 21 CFR 866.3985.