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U.S. Department of Health and Human Services

Product Classification

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Device culture-based short-term incubation antimicrobial resistance assay
Definition A system for detection of microorganisms and antimicrobial resistance using reporter expression is an in vitro diagnostic device intended for the detection and identification of live microorganisms and the detection of associated antimicrobial drug susceptibility or resistance in specimens from patients at risk of colonization or suspected of infection.
Physical State In vitro diagnostic device consisting of reagents and instrumentation for the detection and identification of microorganisms and determination of antimicrobial drug susceptibility or resistance directly in clinical specimens.
Technical Method In vitro diagnostic device that uses expression of transduced reporter genes for the detection and identification of microorganisms and determination of associated antimicrobial drug susceptibility or resistance directly in clinical specimens.
Target Area Clinical specimens from patients suspected of microbial colonization or infection.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodeQIV
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.1655
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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