Cleared Special

BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit

K180438 · Bd · Microbiology

Mar 2018

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K180438 is an FDA 510(k) clearance for the BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Bd (San Diego, US). The FDA issued a Cleared decision on March 20, 2018, 28 days after receiving the submission on February 20, 2018. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K180438 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 20, 2018
Decision Date	March 20, 2018
Days to Decision	28 days
Submission Type	Special
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.