510(k) K230917
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 30, 2023
- Date Received
- April 3, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
- Device Class
- Class II
- Regulation Number
- 866.3230
- Review Panel
- MI
- Submission Type
A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.