Cleared Dual Track

Osom Ultra Plus Flu A&B Test Kit

K192719 · SEKISUI Diagnostics, LLC · Microbiology

Apr 2020

Decision

190d

Days

Class 2

Risk

About This 510(k) Submission

K192719 is an FDA 510(k) clearance for the Osom Ultra Plus Flu A&B Test Kit, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by SEKISUI Diagnostics, LLC (San Diegi, US). The FDA issued a Cleared decision on April 3, 2020, 190 days after receiving the submission on September 26, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K192719 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2019
Decision Date	April 03, 2020
Days to Decision	190 days
Submission Type	Dual Track
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	PSZ — Devices Detecting Influenza A, B, And C Virus Antigens
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3328
Definition	An Influenza Virus Antigen Detection Test System Is A Device Intended For The Qualitative Detection Of Influenza Viral Antigens Directly From Clinical Specimens In Patients With Signs And Symptoms Of Respiratory Infection.