PII · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3960
Classification
FDA Product Code
PII
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3960
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.