DeviceClearance

Product code QXA— Microbiology

FebriDx Bacterial / Non-bacterial Point of Care Assay

Classification name
Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
Device class
Class 2
Regulation
21 CFR 866.3230
Advisory panel
Microbiology
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QXA under 21 CFR 866.3230, via openFDA

Market context for product code QXA

FDA has cleared 2 devices under product code QXA between 2023 and 2026, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QXA

Recent clearances under product code QXA

Data sourced from openFDA. This site is unofficial and independent of the FDA.