FDA Product Code PII: Candida Species Nucleic Acid Detection System
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.
Leading manufacturers include T2biosystems, Inc..
FDA 510(k) Cleared Candida Species Nucleic Acid Detection System Devices (Product Code PII)
About Product Code PII - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code PII since 2014, with 2 receiving FDA clearance (average review time: 137 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under PII have taken an average of 266 days to reach a decision - up from 73 days historically. Manufacturers should account for longer review timelines in current project planning.
PII devices are reviewed by the Microbiology panel. Browse all Microbiology devices →