SCoV-2 Ag Detect Rapid Test
Device Facts
| Record ID | K233358 |
|---|---|
| Device Name | SCoV-2 Ag Detect Rapid Test |
| Applicant | InBios International, Inc. |
| Product Code | QVF · Microbiology |
| Decision Date | Aug 23, 2024 |
| Decision | SESE |
| Submission Type | Dual Track |
| Regulation | 21 CFR 866.3982 |
| Device Class | Class 2 |
Intended Use
The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). This 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 SCoV-2 Ag Detect Rapid Test and followed up with a molecular test. A negative test result is presumptive, and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay. Positive results do not rule out co-infection with other bacteria or viruses and should not be used as tor diagnosis, treatment, or other patient management decisions. Performance characteristics for SARS-CoV-2 were established during the SARS-CoV-2 pandemic from April 2021- April 2024. The dominant variant in circulation varied throughout this period. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.
Device Story
Lateral flow immunochromatographic assay; detects SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens. Used in near-patient settings; operated by healthcare professionals. Provides qualitative visual output; aids in COVID-19 diagnosis. Negative results are presumptive; require molecular confirmation. Positive results do not exclude co-infections. Benefits include rapid identification of SARS-CoV-2 in symptomatic patients.
Clinical Evidence
Performance characteristics established during the SARS-CoV-2 pandemic (April 2021–April 2024).
Technological Characteristics
Lateral flow immunochromatographic assay; anterior nasal swab specimen collection; qualitative visual readout.
Indications for Use
Indicated for symptomatic individuals with signs of upper respiratory tract infection for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in anterior nasal swab specimens.
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.
Related Devices
- K250273 — BinaxNOW COVID-19 Ag Card · Abbott Diagnostics Scarborough, Inc. · Jun 13, 2025
- K240728 — CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag Test · CorDx, Inc. · Jun 21, 2024
- K232377 — Healgen Rapid COVID-19 Antigen Test · Healgen Scientific,, LLC · Apr 19, 2024
- K231187 — Nano-Check COVID-19 Antigen Test · Nano-Ditech Corporation · Jan 23, 2024
Submission Summary (Full Text)
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August 23, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an eagle emblem, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" in a larger font size and a blue square behind it.
InBios International, Inc. Estela Raychaudhuri President 307 Westlake Ave N, Suite 300 Seattle, Washington 98109
Re: K233358
Trade/Device Name: SCoV-2 Ag Detect Rapid Test 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: September 29, 2023 Received: September 29, 2023
Dear Estela Raychaudhuri:
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).
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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 QS 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 (QS) 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 mediation-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,
Image /page/1/Picture/6 description: The image shows the name "Silke Schlottmann -S" in bold font. To the right of the name is the text "Digitally signed by Silke Schlottmann -S" followed by the date "Date: 2024.08.23 16:05:16 -04'00'".
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
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## Indications for Use
510(k) Number (if known) K233358 (CW230020)
Device Name SCoV-2 Ag Detect™ Rapid Test
## Indications for Use (Describe)
The SCOV-2 Ag Detect Rapid Test is a lateral flow immunochromatographic assay for the rapid, qualitative detection of the SARS CoV-2 nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of upper respiratory tract infection (i.e., symptomatic). This 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 SCoV-2 Ag Detect Rapid Test and followed up with a molecular test.
A negative test result is presumptive, and does not preclude SARS-CoV-2 infection; it is recommended these results be confirmed by a molecular SARS-CoV-2 assay.
Positive results do not rule out co-infection with other bacteria or viruses and should not be used as tor diagnosis, treatment, or other patient management decisions.
Performance characteristics for SARS-CoV-2 were established during the SARS-CoV-2 pandemic from April 2021- April 2024. The dominant variant in circulation varied throughout this period. Performance characteristics may vary with newly emerging SARS-CoV-2 virus variants.
Type of Use (Select one or both, as applicable)
| <div> <span style="text-decoration:line-through">[X]</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> [] Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
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