Cleared Traditional

Innovita Flu A/B Antigen Rapid Test

K250398 · Innovita (Tangshan) Biological Technology Co., Ltd. · Microbiology

Jul 2025

Decision

141d

Days

Class 2

Risk

About This 510(k) Submission

K250398 is an FDA 510(k) clearance for the Innovita Flu A/B Antigen Rapid Test, a Devices Detecting Influenza A, B, And C Virus Antigens (Class II — Special Controls, product code PSZ), submitted by Innovita (Tangshan) Biological Technology Co., Ltd. (Qian'An, CN). The FDA issued a Cleared decision on July 3, 2025, 141 days after receiving the submission on February 12, 2025. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3328.

Submission Details

510(k) Number	K250398 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 2025
Decision Date	July 03, 2025
Days to Decision	141 days
Submission Type	Traditional
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.