ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
FDA 510(k) K213236 · Genmark Diagnostics, Incorporated
510(k) numberK213236
Submission
- Device name
- ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel
- Applicant
- Genmark Diagnostics, Incorporated
Carlsbad, CA, US - Received
- September 30, 2021
- Decision date
- April 27, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K243759 | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack)…PEN · Special | Biofire Diagnostics, LLC | 12/20/2024SE |
| 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 |
|---|---|---|
| K182619 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | 04/12/2019SE |
| K182690 | ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) PanelPEO · Traditional | 12/21/2018SE |
| K181663 | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) PanelPAM · Traditional | 12/20/2018SE |
| K163652 | ePlex InstrumentNSU · Traditional | 06/09/2017SE |
| K163636 | ePlex Respiratory Pathogen PanelOCC · Traditional | 06/09/2017SE |
| K152612 | eSensor Warfarin Sensitivity Saliva TestODW · Traditional | 05/26/2016SE |
| K110786 | Esensor Warfarin Sensitivity Saliva TestNSU · Traditional | 12/02/2011SE |
Questions and answers
When was ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel cleared by the FDA?
ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel (K213236) received a 510(k) decision of Substantially Equivalent on April 27, 2022, 209 days after the submission was received.
What is the product code of K213236?
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.