Cleared Dual Track

CareStart Flu A&B Plus

K191514 · Access Bio, Inc. · Microbiology

Feb 2020

Decision

256d

Days

Class 2

Risk

About This 510(k) Submission

K191514 is an FDA 510(k) clearance for the CareStart Flu A&B Plus, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Access Bio, Inc. (Somerset, US). The FDA issued a Cleared decision on February 18, 2020, 256 days after receiving the submission on June 7, 2019. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K191514 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2019
Decision Date	February 18, 2020
Days to Decision	256 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.