Cleared Traditional

iHealth COVID-19 Antigen Rapid Test

K233842 · Ihealth Labs, Inc. · Microbiology

May 2024

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K233842 is an FDA 510(k) clearance for the iHealth COVID-19 Antigen Rapid Test, a Over-the-counter Covid-19 Antigen Test (Class II — Special Controls, product code QYT), submitted by Ihealth Labs, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on May 31, 2024, 179 days after receiving the submission on December 4, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3984.

Submission Details

510(k) Number	K233842 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2023
Decision Date	May 31, 2024
Days to Decision	179 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.