Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart D — Serological Reagents](/submissions/MI/subpart-d%E2%80%94serological-reagents) → [21 CFR 866.3982](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3982) → QWR — Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

# QWR · Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings

_Microbiology · 21 CFR 866.3982 · Class 2_

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

## Overview

- **Product Code:** QWR
- **Device Name:** Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
- **Regulation:** [21 CFR 866.3982](/submissions/MI/subpart-d%E2%80%94serological-reagents/866.3982)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

The Sofia 2 SARS Antigen+ FIA is a lateral flow immunofluorescent sandwich assay used with the Sofia 2 instrument for the rapid, qualitative detection of SARS-CoV-2 nucleocapsid protein antigens directly in anterior nasal swab specimens from symptomatic individuals. It is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19) in symptomatic individuals when tested at least twice over three days with at least 48 hours between tests.

## Classification Rationale

Class II (special controls). The device is a simple qualitative device to directly detect SARS-CoV-2 virus targets in human clinical specimens for settings operating under a certificate of waiver or at home use.

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K243346](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QWR/K243346.md) | cobas liat SARS-CoV-2 v2 nucleic acid test | Roche Molecular Systems, Inc. | Apr 11, 2025 | SESE |
| [K223783](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QWR/K223783.md) | cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System | Roche Molecular Systems, Inc. | Dec 4, 2023 | SESE |
| [K221925](https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/QWR/K221925.md) | ID NOW COVID-19 2.0 | Abbott Diagnostics Scarborough, Inc. | Aug 10, 2023 | SESE |

## Top Applicants

- Roche Molecular Systems, Inc. — 2 clearances
- Abbott Diagnostics Scarborough, Inc. — 1 clearance

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

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