Cleared Traditional

K220963 - Simplexa COVID-19 & Flu A/B Direct (FDA 510(k) Clearance)

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

K220963 · Diasorin Molecular, LLC · Microbiology device
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Mar 2023
Decision
350d
Days
Class 2
Risk

K220963 is an FDA 510(k) clearance for the Simplexa COVID-19 & Flu A/B Direct. Classified as Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents (product code QOF), Class II - Special Controls.

Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on March 17, 2023 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3981 - 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. Elevated predicate reliance profile. 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 Diasorin Molecular, LLC devices

Submission Details

510(k) Number K220963 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2022
Decision Date March 17, 2023
Days to Decision 350 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
248d slower than avg
Panel avg: 102d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3981
Definition A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Microbial Agents That Cause The Sars-cov-2 Respiratory Infection And Other Microbial Agents When In A Multi-target Test Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 And Other Microbial Agents When In A Multi-target Test In Human Clinical Respiratory Specimens From Patients Suspected Of Respiratory Infection Who Are At Risk For Exposure Or Who May Have Been Exposed To These Agents. The Device Is Intended To Aid In The Diagnosis Of Respiratory Infection In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors.
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 - QOF Multi-target Respiratory Specimen Nucleic Acid Test Including Sars-cov-2 And Other Microbial Agents

All 30
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