Cleared Traditional

CareSuperb? COVID-19 Antigen Home Test

K241915 · Access Bio, Inc. · Microbiology

Jan 2025

Decision

212d

Days

Class 2

Risk

About This 510(k) Submission

K241915 is an FDA 510(k) clearance for the CareSuperb? COVID-19 Antigen Home Test, a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by Access Bio, Inc. (Somerset, US). The FDA issued a Cleared decision on January 29, 2025, 212 days after receiving the submission on July 1, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K241915 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 2024
Decision Date	January 29, 2025
Days to Decision	212 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QYT — Over-the-counter Covid-19 Antigen Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3984
Definition	For The Rapid, Qualitative Detection Of Sars-cov-2 Virus Nucleocapsid Protein Antigen In Individuals 2 Years And Older.