Cleared Traditional

K182690 - ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182690 · Genmark Diagnostics, Incorporated · Microbiology device
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Dec 2018
Decision
85d
Days
Class 2
Risk

K182690 is an FDA 510(k) clearance for the ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel. Classified as Fungal Organisms, Nucleic Acid-based Assay (product code PEO), Class II - Special Controls.

Submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on December 21, 2018 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3365 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Genmark Diagnostics, Incorporated devices

Submission Details

510(k) Number K182690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2018
Decision Date December 21, 2018
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 102d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PEO Fungal Organisms, Nucleic Acid-based Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3365
Definition A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Fungal Organisms In Positive Blood Cultures.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.