ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel— 510(k) K181663

Name: FDA 510(k) clearance K181663
Creator: U.S. Food and Drug Administration
Published: 2018-12-20

Substantially Equivalent

Genmark Diagnostics, Incorporated

FDA 510(k) clearance K181663 for ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel, Substantially Equivalent on 2018-12-20. Applicant: Genmark Diagnostics, Incorporated. Device class: 2.

Clearance details

Applicant: Genmark Diagnostics, Incorporated
Product code: Code PAM
Device class: Class 2
Regulation: 21 CFR 866.3365
Advisory panel: Microbiology
Date received: 2018-06-25
Decision date: 2018-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

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K254194 — QIAstat-Dx BCID GPF Plus AMR Panel2026-08-06
K243490 — LIAISON PLEX Gram-Positive Blood Culture Assay2025-06-06
K163390 — iC-GPC Assay TM for use on the iC-SystemTM2017-08-08
K152470 — Great Basin Staph ID/R Blood Culture Panel2016-03-25
K122514 — VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST2012-09-19

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Adverse events under product code PAM

product code PAM

Death: 6
Malfunction: 598
Total: 604

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.