510(k) K193519
- Device
- BioFire Blood Culture Identification 2 (BCID2) Panel
- Applicant
- BioFire Diagnostics, LLC
- 510(k) number
- K193519
- Product code
- PEN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-03-18
- Date received
- 2019-12-19
- Regulation
- 866.3365
- Classification name
- Gram-negative Bacteria And Associated Resistance Markers
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Kristen Kanack
- Address
- 515 Colorow Dr. Salt Lake City UT US 84108 84108
FDA Registration Numbers#
- 3010749841
- 3002773840
- 3006028115
- 3008632402
Source Documents#
Other 510(k) Records For Product Code PEN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay | Luminex Corporation | 2025-04-18 |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | Biofire Diagnostics, LLC | 2024-12-20 |
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated | 2022-04-27 |
| K190341 | iC-GN iC-Cassette for use on the iC-System | Icubate, Inc. | 2019-06-28 |
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | Genmark Diagnostics, Incorporated | 2019-04-12 |
| K181493 | FilmArray Blood Culture Identification (BCID) Panel | Biofire Diagnostics, LLC | 2018-07-05 |
| K160457 | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch | Biofire Diagnostics, LLC | 2016-03-15 |
| K143171 | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2.0 | Biofire Diagnostics, LLC | 2015-01-30 |
| K132843 | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | Nanosphere, Inc. | 2014-01-08 |
| K130914 | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL | Biofire Diagnostics, Inc. | 2013-06-21 |
Legacy Summary#
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FDA Review#
Decision Summary