Cleared Traditional

K262938 - cobas eplex respiratory pathogen panel 3

K262938 is an FDA 510(k) clearance for cobas eplex respiratory pathogen panel 3, manufactured by GenMark Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code QOF cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K262938 · GenMark Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
70d
Days
Class 2
Risk

K262938 is an FDA 510(k) clearance for the cobas eplex respiratory pathogen panel 3. Classified as Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents (product code QOF), Class II - Special Controls.

Submitted by GenMark Diagnostics, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 30, 2026 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3981 - 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.

FDA 510(k) Submission Details - K262938

510(k) Number K262938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2026
Decision Date October 30, 2026
Days to Decision 70 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 102d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QOF Device Classification - Class 2, Special Controls

Product Code QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3981
Definition A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The Sars-cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-target Test Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 And Other Microbial Agents When In A Multi-target Test In Human Clinical Respiratory Specimens From Patients Suspected Of Respiratory Infection Who Are At Risk For Exposure Or Who May Have Been Exposed To These Agents. The Device Is Intended To Aid In The Diagnosis Of Respiratory Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors.
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.

Regulatory Peers - QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents

All 37
Devices cleared under the same product code (QOF) and FDA review panel - the closest regulatory comparables to K262938.
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K262938 · cobas eplex respiratory pathogen panel 3
Download PDF FDA Summary GenMark Diagnostics, …