Simple Point-Of-Care Device To Detect Sar-Cov-2 Nucleic Acid Targets From Clinical Specimens In Near-Patient Settings
QWR · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3982
Classification
FDA Product Code
QWR
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3982
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
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.