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U.S. Department of Health and Human Services

Product Classification
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Device lateral flow immunochromatography assay for host biomarkers of respiratory infection
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.
Physical State In vitro diagnostic device
Technical Method Lateral flow immunochromatography
Target Area Human clinical specimens
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQXA
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3230
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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