Cleared Dual Track

Acucy Influenza A&B Test with the Acucy System

K182001 · SEKISUI Diagnostics, LLC · Microbiology

Dec 2018

Decision

144d

Days

Class 2

Risk

About This 510(k) Submission

K182001 is an FDA 510(k) clearance for the Acucy Influenza A&B Test with the Acucy System, 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 December 17, 2018, 144 days after receiving the submission on July 26, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K182001 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2018
Decision Date	December 17, 2018
Days to Decision	144 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.