510(k) K221925

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

August 10, 2023

Date Received

July 1, 2022

Clearance Type

Dual Track

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

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

Device Class

Class II

Regulation Number

866.3982

Review Panel

MI

Submission Type

A simple point-of-care device to detect SARS-CoV-2 nucleic acid targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections (COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to another functional area (e.g., a central laboratory or other specialized area), or measurement of reagents or analytes that could be affected by conditions such as sample turbidity or cell lysis. The design and procedures of the device are appropriate for use by healthcare professionals in near-patient settings outside a centralized laboratory.