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U.S. Department of Health and Human Services

Product Classification

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Device candida species nucleic acid detection system
Regulation Description Nucleic acid-based device for the amplification, detection, and identification of microbial pathogens directly from whole blood specimens.
Definition The Candida species nucleic acid detection system is a qualitative panel for the direct detection of Candida species in whole blood specimens from patients with symptoms of, or medical conditions predisposing the patients to, invasive fungal infections. The test is indicated for the presumptive diagnosis of candidemia. The test is performed independent of blood culture. Concomitant blood cultures are necessary to recover organisms for susceptibility testing or further identification.
Physical State The Candida species nucleic acid detection system consists of reagents and disposables and accompanying positive and negative controls. The associated instrumentation performs the amplification of the Candida nucleic acid, detects the amplified products, and reports results.
Technical Method A multiplexed nucleic acid amplification assay that amplifies and detects Candida DNA in whole blood specimens.
Target Area Nucleic acids of Candida species.
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePII
Premarket Review Division of Microbiology Devices (DMD)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.3960
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible