510(k) K234063

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

September 13, 2024

Date Received

December 22, 2023

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Candida Species Nucleic Acid Detection System

Device Class

Class II

Regulation Number

866.3960

Review Panel

MI

Submission Type

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.