SCA · Multi-Analyte Respiratory Virus Antigen Detection Test
Microbiology · 21 CFR 866.3987 · Class 2
Overview
| Product Code | SCA |
|---|---|
| Device Name | Multi-Analyte Respiratory Virus Antigen Detection Test |
| Regulation | 21 CFR 866.3987 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
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 Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro | Ihealth Labs, Inc. | Dec 12, 2025 | SESE |
| K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro | Ihealth Labs, Inc. | Dec 12, 2025 | SESE |
| K251538 | Status COVID-19/Flu A&B | Princeton BioMeditech Corp. | Nov 14, 2025 | SESE |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. | Oct 22, 2025 | SESE |
| K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. | Aug 22, 2025 | SESE |
| K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | Wondfo USA Co, Ltd. | Aug 20, 2025 | SESE |
| K243561 | Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation | Jun 17, 2025 | SESE |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | ACON Laboratories, Inc. | May 10, 2025 | SESE |
| K243256 | WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest | Wondfo USA Co, Ltd. | Jan 16, 2025 | SESE |
| K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | Osang, LLC | Jan 13, 2025 | SESE |
| DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test | Healgen | Oct 7, 2024 | DENG |
Top Applicants
- Wondfo USA Co, Ltd. — 2 clearances
- Ihealth Labs, Inc. — 2 clearances
- ACON Laboratories, Inc. — 2 clearances
- Princeton BioMeditech Corp. — 1 clearance
- Osang, LLC — 1 clearance
