Cleared Traditional

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

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

K181663 · Genmark Diagnostics, Incorporated · Microbiology device
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Dec 2018
Decision
178d
Days
Class 2
Risk

K181663 is an FDA 510(k) clearance for the ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel. Classified as Gram-positive Bacteria And Their Resistance Markers (product code PAM), Class II - Special Controls.

Submitted by Genmark Diagnostics, Incorporated (Carlsbad, US). The FDA issued a Cleared decision on December 20, 2018 after a review of 178 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Genmark Diagnostics, Incorporated devices

Submission Details

510(k) Number K181663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 2018
Decision Date December 20, 2018
Days to Decision 178 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
76d slower than avg
Panel avg: 102d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PAM Gram-positive Bacteria And Their Resistance Markers
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3365
Definition A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers 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.