Cleared Special

K181436 - OSOM Mono Test (FDA 510(k) Clearance)

Also includes:
Sure Vue Signature Mono ImmunoCard STAT Mono Cardinal Health Mono II Rapid Test

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K181436 · SEKISUI Diagnostics, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
21d
Days
Class 2
Risk

K181436 is an FDA 510(k) clearance for the OSOM Mono Test. Classified as System, Test, Infectious Mononucleosis (product code KTN), Class II - Special Controls.

Submitted by SEKISUI Diagnostics, LLC (San Diego, US). The FDA issued a Cleared decision on June 22, 2018 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5640 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all SEKISUI Diagnostics, LLC devices

Submission Details

510(k) Number K181436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2018
Decision Date June 22, 2018
Days to Decision 21 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KTN System, Test, Infectious Mononucleosis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5640
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.