SCA — Multi-Analyte Respiratory Virus Antigen Detection Test Class II
FDA product code SCA covers "Multi-Analyte Respiratory Virus Antigen Detection Test", a Class II medical device regulated under 21 CFR 866.3987. Submissions are reviewed by the Microbiology panel. At least 12 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K261212 | acon laboratories | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | July 10, 2026 |
| 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 |