SCA — Multi-Analyte Respiratory Virus Antigen Detection Test Class II
Classification Details
- Product Code
- SCA
- Device Class
- Class II
- Regulation Number
- 866.3987
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Definition
A multi-analyte respiratory virus antigen detection test is an in vitro diagnostic device intended for the detection and/or differentiation of respiratory viruses directly from respiratory clinical specimens. The device is intended to be performed at the site of sample collection, does not involve sample storage and/or transport.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251085 | ihealth labs | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test | December 12, 2025 |
| K251092 | ihealth labs | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | December 12, 2025 |
| K251538 | princeton biomeditech | Status COVID-19/Flu A&B | November 14, 2025 |
| K251749 | acon laboratories | Flowflex Plus RSV + Flu A/B + COVID Home Test | October 22, 2025 |
| K251604 | access bio | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | August 22, 2025 |
| K251563 | wondfo usa co | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | August 20, 2025 |
| K243561 | nano-ditech corporation | Nano-Check Influenza+COVID-19 Dual Test | June 17, 2025 |
| K250377 | acon laboratories | Flowflex Plus COVID-19 + Flu A/B Home Test | May 10, 2025 |
| K243256 | wondfo usa co | WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B | January 16, 2025 |
| K243262 | osang | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pr | January 13, 2025 |
| DEN240029 | healgen | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | October 7, 2024 |