Cleared Traditional

K243274 - CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) (FDA 510(k) Clearance)

Also includes:
Influenza A SubTyping Kit (VER 4) Influenza B Genotyping Kit (VER 1.1 and 2) and Influenza A/H5 Subtyping Kit (VER 4)

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

K243274 · Centers For Disease Control and Prevention · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2025
Decision
268d
Days
Class 2
Risk

K243274 is an FDA 510(k) clearance for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Ty.... Classified as Influenza A And Influenza B Multiplex Nucleic Acid Assay (product code OZE), Class II - Special Controls.

Submitted by Centers For Disease Control and Prevention (Atlanta, US). The FDA issued a Cleared decision on July 11, 2025 after a review of 268 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - 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 Centers For Disease Control and Prevention devices

Submission Details

510(k) Number K243274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2024
Decision Date July 11, 2025
Days to Decision 268 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 102d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition An Influenza A And Influenza B Multiplex Nucleic Acid Assay Is A Multiplex In Vitro Diagnostic Test For The Simultaneous Qualitative Detection And Discrimination Of Influenza A And Influenza B Nucleic Acids Isolated And Purified From Human Respiratory Specimens Obtained From Individuals Exhibiting Signs And Symptoms Of Respiratory Tract Infections Or Viral Culture. The Detection And Discrimination Of Influenza A And B Nucleic Acids From Symptomatic Patients Aid In The Diagnosis Of Human Respiratory Tract Influenza Viral Infections If Used In Conjunction With Other Clinical And Laboratory Findings.
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 Peers - OZE Influenza A And Influenza B Multiplex Nucleic Acid Assay

All 19
Devices cleared under the same product code (OZE) and FDA review panel - the closest regulatory comparables to K243274.
CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2)
K243931 · Centers For Disease Control and Prevention · Mar 2025
CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4)
K241110 · Centers For Disease Control and Prevention · May 2024
Lyra Influenza A+B Assay
K230236 · Quidel Corporation · Mar 2023