Cleared Special

K233688 - Sofia 2 SARS Antigen+ FIA (FDA 510(k) Clearance)

Also includes:
Sofia 2 SARS Antigen+ FIA Control Swab Set

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K233688 · Quidel Corporation · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
26d
Days
Class 2
Risk

K233688 is an FDA 510(k) clearance for the Sofia 2 SARS Antigen+ FIA. Classified as Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings (product code QVF), Class II - Special Controls.

Submitted by Quidel Corporation (San Diego, US). The FDA issued a Cleared decision on December 13, 2023 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3982 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Quidel Corporation devices

Submission Details

510(k) Number K233688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2023
Decision Date December 13, 2023
Days to Decision 26 days
Submission Type Special
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
76d faster than avg
Panel avg: 102d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code QVF Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3982
Definition A Simple Point-of-care Device To Detect Sars-cov-2 Viral Targets Directly From Clinical Specimens In Near-patient Settings Is An In Vitro Diagnostic Device For The Direct Detection Of Sars-cov-2 In Clinical Specimens And Is Intended As An Aid In The Diagnosis Of Sars-cov-2 Infections Covid-19). The Device Is Simple To Use And Does Not Involve Sample Manipulation, Transportation Of The Sample To Another Functional Area (e.g., A Central Laboratory Or Other Specialized Area), Or Measurement Of Reagents Or Analytes That Could Be Affected By Conditions Such As Sample Turbidity Or Cell Lysis. The Design And Procedures Of The Device Are Appropriate For Use By Healthcare Professionals In Near-patient Settings Outside A Centralized Laboratory
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 - QVF Simple Point-of-care Device To Directly Detect Sars-cov-2 Viral Targets From Clinical Specimens In Near-patient Settings

All 7
Devices cleared under the same product code (QVF) and FDA review panel - the closest regulatory comparables to K233688.
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