Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

K233688 · Quidel Corporation · QVF · Dec 13, 2023 · Microbiology

Device Facts

• Record ID: K233688
• Device Name: Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set
• Applicant: Quidel Corporation
• Product Code: QVF · Microbiology
• Decision Date: Dec 13, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3982
• Device Class: Class 2

Indications for Use

The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory infection (i.e., symptomatic) when testing is started within 6 days of symptom onset. The test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when either: tested at least twice over three days with at least 48 hours between tests; or when tested once, and negative by the Sofia 2 SARS Antigen+ FIA and followed up with a molecular test. The test does not differentiate between SARS-CoV and SARS-CoV-2. A negative test result is presumptive, and it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with bacteria or other viruses and should not be used as the sole basis for treatment or other patient management decisions. Performance characteristics for SARS-CoV-2 were established during the 2021-2022 SARS-CoV-2 pandemic when SARS CoV 2 Omicron was the predominant SARS-CoV-2 variant in circulation. When other SARS-CoV-2 virus variant are emerging, performance characteristics may vary. This test is intended for prescription use only and can be used in Point-of-Care settings.

Device Story

Lateral flow immunofluorescent sandwich assay; detects SARS-CoV-2 nucleocapsid protein in anterior nasal swabs. Sample placed in reagent tube for viral disruption; dispensed into test cassette. Nitrocellulose strip contains immobilized monoclonal antibodies; fluorescent micro-particles coated with monoclonal antibodies bind viral antigen. Sofia 2 instrument automatically scans/images test strip; collects/analyzes fluorescence data; reports positive, negative, or invalid results. No visual interpretation possible. Used in point-of-care settings by healthcare professionals. Provides rapid qualitative results to aid clinical diagnosis; negative results require molecular confirmation. Benefits include rapid identification of SARS-CoV-2 to inform patient management.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and technological similarity to the predicate device.

Technological Characteristics

Lateral flow immunofluorescent sandwich assay; nitrocellulose membrane; fluorescent micro-particles; monoclonal antibodies. Instrument-based detection (Sofia 2 reader). Standalone test cassette. No specific material standards cited.

Indications for Use

Indicated for symptomatic individuals with signs of upper respiratory infection within 6 days of symptom onset for qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in anterior nasal swabs. Used as an aid in COVID-19 diagnosis via serial testing (twice over 3 days, 48h apart) or single test followed by molecular confirmation if negative. Prescription use in point-of-care settings.

Regulatory Classification

Identification

The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent sandwich assay used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from symptomatic individuals. It is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests.

Predicate Devices

• Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set (DEN220039)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K233688

B Applicant

Quidel Corporation

C Proprietary and Established Names

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| QVF | Class II | 21 CFR 866.3982 - Simple Point-Of-Care Device To Directly Detect SARS-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own Class II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER’s previously cleared device.
2. A description of the device labeling modifications, including sufficient detail to demonstrate that the fundamental scientific technology of the modified device has not changed. These changes were to revise the intended use to: 1) clarify that serial testing with an antigen test may be omitted if primary testing is instead followed up with molecular testing; and 2) clarify statements regarding result interpretation to align with the Special Controls described in 21 CFR 866.3982.
3. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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4. A Summary of Design Control Activities was not provided nor requested, as the labeling modifications proposed therein identified no new risk or significantly modified existing risk and did not indicate that the modifications had the potential to affect product performance.

The labeling for this modified subject device has been reviewed to verify that the instructions for use have been modified to reflect the updated intended use. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. On this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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