PEN — Gram-Negative Bacteria And Associated Resistance Markers Class II
FDA product code PEN covers "Gram-Negative Bacteria And Associated Resistance Markers", a Class II medical device regulated under 21 CFR 866.3365. Submissions are reviewed by the Microbiology panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PEN
- Device Class
- Class II
- Regulation Number
- 866.3365
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243013 | luminex corporation | LIAISON PLEX Gram-Negative Blood Culture Assay | April 18, 2025 |
| K243759 | biofire diagnostics | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RF | December 20, 2024 |
| K213236 | genmark diagnostics, incorporated | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | April 27, 2022 |
| K193519 | biofire diagnostics | BioFire Blood Culture Identification 2 (BCID2) Panel | March 18, 2020 |
| K190341 | icubate | iC-GN iC-Cassette for use on the iC-System | June 28, 2019 |
| K182619 | genmark diagnostics, incorporated | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | April 12, 2019 |
| K181493 | biofire diagnostics | FilmArray Blood Culture Identification (BCID) Panel | July 5, 2018 |
| K160457 | biofire diagnostics | FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch | March 15, 2016 |
| K143171 | biofire diagnostics | FilmArray Blood Culture Identification (BCID) Panel for use with the FilmArray 2 | January 30, 2015 |
| K132843 | nanosphere | VERIGENE GRAM NEGATIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GN) | January 8, 2014 |
| K130914 | biofire diagnostics | FILMARRAY BLOOD CULTURE IDENTIFICATION (BCID) PANEL | June 21, 2013 |