FDA Product Code QXA: Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
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.
Leading manufacturers include Lumos Diagnostics, Inc..
FDA 510(k) Cleared Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection Devices (Product Code QXA)
About Product Code QXA - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QXA since 2023, with 2 receiving FDA clearance (average review time: 51 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QXA have taken an average of 14 days to reach a decision - down from 88 days historically, suggesting improved FDA processing for this classification.
QXA devices are reviewed by the Microbiology panel. Browse all Microbiology devices →