Cleared Traditional

K250398 - Innovita Flu A/B Antigen Rapid Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K250398 · Innovita (Tangshan) Biological Technology Co., Ltd. · Microbiology device
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Jul 2025
Decision
141d
Days
Class 2
Risk

K250398 is an FDA 510(k) clearance for the Innovita Flu A/B Antigen Rapid Test. Classified as Devices Detecting Influenza A, B, And C Virus Antigens (product code PSZ), Class II - Special Controls.

Submitted by Innovita (Tangshan) Biological Technology Co., Ltd. (Qian'An, CN). The FDA issued a Cleared decision on July 3, 2025 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3328 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovita (Tangshan) Biological Technology Co., Ltd. devices

Submission Details

510(k) Number K250398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 102d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSZ Devices Detecting Influenza A, B, And C Virus Antigens
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Consultant

LSI International, Inc.
Jenny Xia

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - PSZ Devices Detecting Influenza A, B, And C Virus Antigens

All 71
Devices cleared under the same product code (PSZ) and FDA review panel - the closest regulatory comparables to K250398.
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