(26 days)
Not Found.
No
The description focuses on the lateral flow immunofluorescent assay and the Sofia 2 instrument's function of scanning, collecting, and analyzing fluorescence data, which is standard for this type of device and does not explicitly mention or imply the use of AI or ML for interpretation or analysis beyond basic signal processing.
No
This device is a diagnostic test kit used to detect SARS-CoV-2 nucleocapsid protein antigens, aiding in the diagnosis of COVID-19, rather than providing therapy or treatment.
Yes
The text explicitly states that the device is "intended for use as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19)".
No
The device is a lateral flow immunofluorescent sandwich assay that requires a physical test strip and a Sofia 2 instrument for analysis, indicating it is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's 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... as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19)". This clearly indicates it's used to test human specimens to provide information for diagnosis.
- Device Description: The description details a "lateral flow immunofluorescent sandwich assay" that analyzes a "human anterior nasal swab specimen" to detect viral antigens. This is a typical description of an in vitro diagnostic test.
- Specimen Type: It uses "anterior nasal swab specimens", which are human biological samples.
- Purpose: The purpose is to detect the presence of a specific analyte (SARS-CoV-2 nucleocapsid protein antigens) in a human sample to aid in the diagnosis of a disease (COVID-19).
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Sofia 2 SARS Antigen+ FIA Control Swab Set:
The Sofia 2 SARS Antigen+FIA Control Swabs are intended to be used as quality control samples with the Sofia 2 SARS Antigen+ FIA and are representative of positive and negative test samples. These Controls may be used to demonstrate that the reagents and assay procedure perform properly.
Product codes (comma separated list FDA assigned to the subject device)
QVF
Device Description
The Sofia 2 SARS Antigen+FIA is based upon a lateral flow technology that employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from the SARS-CoV-2 virus in human anterior nasal swab specimens.
The patient sample is placed in the Reagent Tube, during which time the virus particles in the sample are disrupted, exposing internal viral nucleoproteins. After disruption, the sample is dispensed into the Test Cassette sample well. The Test Strip is composed of the following biochemical components dried and immobilized onto the nitrocellulose membrane: 1) sample pad that receives the specimen: 2) a label pad that contains detection fluorescent micro-particles, coated with monoclonal antibodies that are specific for SARS-CoV-2 nucleocapsid antigen; 3) embedded monoclonal antibodies specific for SARS-CoV-2 nucleocapsid antigen to capture the antigen-microparticle complex at the tocation. The sample pad facilitates migration of the sample fluid across the nitrocellulose strip into the absorbent pad (See Figure 4-1 in attachment). The test strip also contains a desiccant that does not participate in the assay but serves as a stabilizing agent during storage.
Sample is applied to in the sample well and migrates through a test strip, then passes through the test and control lines. If SARS-CoV-2 viral antigen is present, they will be bound by the fluorescent microparticles io the label pad reqion, forming an antigen-microparticle complex.
The test line is coated with monoclonal antibodies that are specific to SARS-CoV-2 nucleocapsid antigen and is intended to capture the antigen-microparticle complex. If SARS-CoV-2 viral antigen is not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia 2.
The Sofia 2 SARS Antigen+ FIA employs antibody tagged microparticles dyed with a fluorescent compound, to be detected and read by the Sofia 2 reader instrument. The Sofia 2 analyzers automatically scan/image the test strip, collect and analyze the fluorescence data, and report the result as either positive, negative, or invalid.
Additionally, the Sofia 2 Antigen+ FIA utilizes a reference line for the Sofia 2 reader (to locate the test line and negative control line) and a procedural control (to assess for sample presence and adequate sample flow). No colored lines will be visible in the test window of the fluorescent assay cassette, thereby preventing visual interpretation of the test results. The operator must use the Sofia 2 analyzer to obtain a test result.
The Sofia 2 SARS Antigen+ FIA Control Swabs are intended to be used as quality control samples representative of positive and neqative test samples, to demonstrate that the reagents are that the assay procedure is correctly perform.
Mentions image processing
The Sofia 2 analyzers automatically scan/image the test strip, collect and analyze the fluorescence data, and report the result as either positive, negative, or invalid.
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Not Found.
Anatomical Site
anterior nasal swab specimens
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
prescription use only and can be used in Point-of-Care settings.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found.
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
Quidel Corporation Xiaoxi Wang Senior Regulatory Affairs Specialist 10165 McKellar Court San Diego, California 92121
December 13, 2023
Re: K233688
Trade/Device Name: Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set Regulation Number: 21 CFR 866.3982 Regulation Name: Simple Point-Of-Care Device To Directly Detect SARS-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings Regulatory Class: Class II Product Code: QVF Dated: November 16, 2023 Received: November 17, 2023
Dear Xiaoxi Wang:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Silke Digitally signed by Silke Schlottmann -S Schlottmann -S Date: 2023.12.13 19:30:57 Silke Schlottmann, Ph.D. Deputy Assistant Director
Bacteriology Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Sofia 2 SARS Antigen+ FIA (20405); Sofia 2 SARS Antigen+ FIA Control Swab Set (20482) Indications for Use (Describe)
Sofia 2 SARS Antigen+ FIA:
The Sofia 2 SARS Antigen+ FlA 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 neqative 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.
Performanc 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.
Sofia 2 SARS Antigen+ FIA Control Swab Set:
The Sofia 2 SARS Antigen+FIA Control Swabs are intended to be used as quality control samples with the Sofia 2 SARS Antigen+ FIA and are representative of positive and negative test samples. These Controls may be used to demonstrate that the reagents and assay procedure perform properly.
Type of Use (Select one or both, as applicable)
escription Use (Part 21 CFR 801 Subpart D)
ter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
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4
K233688: Sofia 2 SARS Antigen+ FIA
Contact Details
| Applicant Name | Quidel Corporation |
|---|---|
| Applicant Address | 10165 McKellar Court, San Diego, CA 92121, United States |
| Applicant Contact Telephone | 619-679-4339 |
| Applicant Contact | Ms. Xiaoxi Wang |
| Applicant Contact Email | xiaoxi.wang@quidelortho.com |
Device Name
| Device Trade Name | Sofia 2 SARS Antigen+ FIA:
Sofia 2 SARS Antigen+ FIA Control Swab Set |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Common Name | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set |
| Classification Name | Simple point-of-care device to directly detect SARS-CoV-2 viral targets
from clinical specimens in near-patient settings |
| Regulation Number | 21 CFR 866.3982 |
| Product Code | QVF |
Legally Marketed Predicate Device
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| DEN220039 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA | |
| Control Swab Set | QVF |
Device Description Summary
21 CFR 807.92(a)(4)
21 CFR 807.92(a)(3)
The Sofia 2 SARS Antigen+FIA is based upon a lateral flow technology that employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from the SARS-CoV-2 virus in human anterior nasal swab specimens.
The patient sample is placed in the Reagent Tube, during which time the virus particles in the sample are disrupted, exposing internal viral nucleoproteins. After disruption, the sample is dispensed into the Test Cassette sample well. The Test Strip is composed of the following biochemical components dried and immobilized onto the nitrocellulose membrane: 1) sample pad that receives the specimen: 2) a label pad that contains detection fluorescent micro-particles, coated with monoclonal antibodies that are specific for SARS-CoV-2 nucleocapsid antigen; 3) embedded monoclonal antibodies specific for SARS-CoV-2 nucleocapsid antigen to capture the antigen-microparticle complex at the tocation. The sample pad facilitates migration of the sample fluid across the nitrocellulose strip into the absorbent pad (See Figure 4-1 in attachment). The test strip also contains a desiccant that does not participate in the assay but serves as a stabilizing agent during storage.
Sample is applied to in the sample well and migrates through a test strip, then passes through the test and control lines. If SARS-CoV-2 viral antigen is present, they will be bound by the fluorescent microparticles io the label pad reqion, forming an antigen-microparticle complex.
The test line is coated with monoclonal antibodies that are specific to SARS-CoV-2 nucleocapsid antigen and is intended to capture the antigen-microparticle complex. If SARS-CoV-2 viral antigen is not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia 2.
The Sofia 2 SARS Antigen+ FIA employs antibody tagged microparticles dyed with a fluorescent compound, to be detected and read by the Sofia 2 reader instrument. The Sofia 2 analyzers automatically scan/image the test strip, collect and analyze the fluorescence data, and report the result as either positive,
510(k) Summary
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(2)
Prepared on: 2023-11-16
5
negative, or invalid.
Additionally, the Sofia 2 Antigen+ FIA utilizes a reference line for the Sofia 2 reader (to locate the test line and negative control line) and a procedural control (to assess for sample presence and adequate sample flow). No colored lines will be visible in the test window of the fluorescent assay cassette, thereby preventing visual interpretation of the test results. The operator must use the Sofia 2 analyzer to obtain a test result.
The Sofia 2 SARS Antigen+ FIA Control Swabs are intended to be used as quality control samples representative of positive and neqative test samples, to demonstrate that the reagents are that the assay procedure is correctly perform.
Intended Use/Indications for Use (Predicate Device) 21 CFR 807.92(a)(5)
Sofia 2 SARS Antigen+ FIA
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 tested at least twice over three days with at least 48 hours between tests.
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. Negative results do not preclude SARS-CoV-2 infections and should not be used as the sole basis for treatment or other patient management decisions.
Positive results do not rule out co-infection with other respiratory pathogens.
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.
Sofia 2 SARS Antigen+ FIA Control Swab Set
The Sofia 2 SARS Antigen+ FIA Control Swabs are intended to be used as quality control samples with the Sofia 2 SARS Antigen+ FIA and are representative of positive test samples. These Controls may be used to demonstrate that the reagents and assay procedure perform properly.
| Indications for Use Comparison | 21 CFR 807.92(a)(5) | |
|---|---|---|
| Device & Predicate | ||
| Device(s): | K233688 | DEN220039 |
| Intended | ||
| Use/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 | 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 |
6
| 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. | when tested at least twice over three days
with at least 48 hours between tests. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The test does not differentiate between
SARS-CoV and SARS-CoV-2. | 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. | A negative test result is presumptive, and
it is recommended these results be
confirmed by a molecular SARS-CoV-2
assay. Negative results do not preclude
SARS-CoV-2 infections and should not be
used as the sole basis for treatment or
other patient management decisions. |
| Positive results do not rule out co-infection
with bacteria or other viruses and should
not be used as the sole basis for
diagnosis, treatment, or other patient
management decisions. | Positive results do not rule out co-
infection with other respiratory pathogens. |
| 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. | 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. | This test is intended for prescription use
only and can be used in Point-of-Care
settings. |
Technological Comparison
21 CFR 807.92(a)(6)
The Sofia 2 SARS Antigen + FIA was modified to include minor revisions to intended use statement on labeling. The proposed labeling modifications of the Sofia 2 SARS Antigen + FIA do not impact the device's substantial equivalence to the previously cleared version of this device is as safe, as effective, and performs as well as the predicate device. The design, material, chemical composition, principle of operation are substantially equivalent to the predicate device.
| Non-Clinical and/or Clinical Tests Summary & |
|---|
| Conclusions |
| Not applicable. |
21 CFR 807.92(b)