PII — Candida Species Nucleic Acid Detection System Class II

FDA Device Classification

Classification Details

Product Code
PII
Device Class
Class II
Regulation Number
866.3960
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K234063t2biosystemsT2Candida 1.1 PanelSeptember 13, 2024
K173536t2biosystemsT2Candida 1.1 PanelDecember 12, 2017
DEN140019t2biosystemsT2CANDIDA AND T2DX INSTRUMENTSeptember 22, 2014