ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
FDA 510(k) K181663 · Genmark Diagnostics, Incorporated
510(k) numberK181663
Submission
- Device name
- ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
- Applicant
- Genmark Diagnostics, Incorporated
Carlsbad, CA, US - Received
- June 25, 2018
- Decision date
- December 20, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAM – Gram-Positive Bacteria And Their Resistance Markers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3365
- Specialty
- Microbiology
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Other 510(k)s with product code PAM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254194 | QIAstat-Dx BCID GPF Plus AMR PanelPAM · Traditional | QIAGEN GmbH | 08/06/2026SE |
| K243490 | LIAISON PLEX Gram-Positive Blood Culture AssayPAM · Traditional | Luminex Corporation | 06/06/2025SE |
| K163390 | iC-GPC Assay TM for use on the iC-SystemTMPAM · Traditional | Icubate, Inc. | 08/08/2017SE |
| K152470 | Great Basin Staph ID/R Blood Culture PanelPAM · Traditional | Great Basin Scientific, Inc. | 03/25/2016SE |
| K122514 | Verigene Gram-Positive Blood Culture (Gc-Gp) Nucleic Acid TestPAM · Traditional | Nanosphere, Inc. | 09/19/2012SE |
More from Nanosphere, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K213236 | ePlex Blood Culture Identification Gram Negative (BCID-GN) PanelPEN · Traditional | 04/27/2022SE |
| 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 |
| 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 Panel - Gram Positive (BCID-GP) Panel cleared by the FDA?
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (K181663) received a 510(k) decision of Substantially Equivalent on December 20, 2018, 178 days after the submission was received.
What is the product code of K181663?
The FDA product code is PAM – Gram-Positive Bacteria And Their Resistance Markers, a Class II (moderate risk) device regulated under 21 CFR 866.3365.