510(k) K230917
K230917 is an FDA 510(k) premarket notification submitted by Lumos Diagnostics, Inc. for the device "FebriDx Bacterial / Non-bacterial Point of Care Assay". The FDA issued a decision of Substantially Equivalent on Jun 30, 2023. The device falls under product code QXA (Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection), a Class II device regulated under 21 CFR 866.3230. Lumos Diagnostics, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 30, 2023
- Date Received
- Apr 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.