SCA
- Product code
- SCA
- Device name
- Multi-Analyte Respiratory Virus Antigen Detection Test
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3987
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 12
- Summaries archived here
- 8 (direct download)
- 510(k) clearances (all years, FDA)
- 12 (all years; only the last 3 years are listed here)
FDA classification 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.
510(k) clearances, last 3 years (12)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261212 | 2026-07-10 | ACON Laboratories, Inc. | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | — |
| K251085 | 2025-12-12 | Ihealth Labs, Inc. | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu… | |
| K251092 | 2025-12-12 | Ihealth Labs, Inc. | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B… | |
| K251538 | 2025-11-14 | Princeton BioMeditech Corp. | Status COVID-19/Flu A&B | |
| K251749 | 2025-10-22 | ACON Laboratories, Inc. | Flowflex Plus RSV + Flu A/B + COVID Home Test | — |
| K251604 | 2025-08-22 | Access Bio, Inc. | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | |
| K251563 | 2025-08-20 | Wondfo USA Co, Ltd. | WELLlife Flu A&B Home Test; WELLlife Influenza A&B T… | |
| K243561 | 2025-06-17 | Nano-Ditech Corporation | Nano-Check Influenza+COVID-19 Dual Test | |
| K250377 | 2025-05-10 | ACON Laboratories, Inc. | Flowflex Plus COVID-19 + Flu A/B Home Test | — |
| K243256 | 2025-01-16 | Wondfo USA Co, Ltd. | WELLlife COVID-19 / Influenza A&B Home Test; WELLli… | |
| K243262 | 2025-01-13 | Osang, LLC | QuickFinder COVID-19/Flu Antigen Self Test / QuickFi… | |
| DEN240029 | 2024-10-07 | Healgen | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | — |
Official FDA classification page: SCA
Classification and pathway per current FDA publications. Data from openFDA (CC0).