BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
FDA 510(k) K243759 · Biofire Diagnostics, LLC
510(k) numberK243759
Submission
- Device name
- BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))
- Applicant
- Biofire Diagnostics, LLC
Salt Lake City, UT, US - Received
- December 6, 2024
- Decision date
- December 20, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEN – Gram-Negative Bacteria And Associated Resistance Markers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3365
- Specialty
- Microbiology
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Other 510(k)s with product code PEN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243013 | LIAISON PLEX Gram-Negative Blood Culture AssayPEN · Traditional | Luminex Corporation | 04/18/2025SE |
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | Genmark Diagnostics, Incorporated | 04/27/2022SE |
| K193519 | BioFire Blood Culture Identification 2 (BCID2) PanelPEN · Traditional | Biofire Diagnostics, LLC | 03/18/2020SE |
| K190341 | iC-GN iC-Cassette for use on the iC-SystemPEN · Traditional | Icubate, Inc. | 06/28/2019SE |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | Genmark Diagnostics, Incorporated | 04/12/2019SE |
| K181493 | FilmArray Blood Culture Identification (BCID) PanelPEN · Special | Biofire Diagnostics, LLC | 07/05/2018SE |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray TorchPEN · Special | Biofire Diagnostics, LLC | 03/15/2016SE |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0PEN · Traditional | Biofire Diagnostics, LLC | 01/30/2015SE |
| K132843 | Verigene Gram Negative Blood Culture Nucleic Acid Test (Bc-Gn)PEN · Traditional | Nanosphere, Inc. | 01/08/2014SE |
| K130914 | Filmarray Blood Culture Identification (Bcid) PanelPEN · Traditional | Biofire Diagnostics, Inc. | 06/21/2013SE |
More from Biofire Diagnostics, Inc.
| 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 |
| 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 |
| K212727 | FilmArray Pneumonia PanelQDP · Special | 09/22/2021SE |
Questions and answers
When was BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) cleared by the FDA?
BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) (K243759) received a 510(k) decision of Substantially Equivalent on December 20, 2024, 14 days after the submission was received.
What is the product code of K243759?
The FDA product code is PEN – Gram-Negative Bacteria And Associated Resistance Markers, a Class II (moderate risk) device regulated under 21 CFR 866.3365.