Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3987](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3987) → SCA — Multi-Analyte Respiratory Virus Antigen Detection Test

# SCA · Multi-Analyte Respiratory Virus Antigen Detection Test

_Microbiology · 21 CFR 866.3987 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA

## Overview

- **Product Code:** SCA
- **Device Name:** Multi-Analyte Respiratory Virus Antigen Detection Test
- **Regulation:** [21 CFR 866.3987](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3987)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## 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](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K251092.md) | 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](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K251085.md) | 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](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K251538.md) | Status™ COVID-19/Flu A&B | Princeton BioMeditech Corp. | Nov 14, 2025 | SESE |
| [K251749](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K251749.md) | Flowflex Plus RSV + Flu A/B + COVID Home Test | ACON Laboratories, Inc. | Oct 22, 2025 | SESE |
| [K251604](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K251604.md) | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test | Access Bio, Inc. | Aug 22, 2025 | SESE |
| [K251563](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K251563.md) | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test | Wondfo USA Co, Ltd. | Aug 20, 2025 | SESE |
| [K243561](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K243561.md) | Nano-Check Influenza+COVID-19 Dual Test | Nano-Ditech Corporation | Jun 17, 2025 | SESE |
| [K250377](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K250377.md) | Flowflex Plus COVID-19 + Flu A/B Home Test | ACON Laboratories, Inc. | May 10, 2025 | SESE |
| [K243256](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K243256.md) | WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest | Wondfo USA Co, Ltd. | Jan 16, 2025 | SESE |
| [K243262](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/K243262.md) | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | Osang, LLC | Jan 13, 2025 | SESE |
| [DEN240029](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA/DEN240029.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/SCA)

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