| 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 Code | PII |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
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
Reporting |
Eligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
