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..
3
Total
2
Cleared
137d
Avg days
2014
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Candida Species Nucleic Acid Detection System Devices (Product Code PII)
3 devices
Cleared
Sep 13, 2024
T2Candida 1.1 Panel
T2biosystems, Inc.
Microbiology
266d
Cleared
Dec 12, 2017
T2Candida 1.1 Panel
T2biosystems, Inc.
Microbiology
27d
Not Cleared
Sep 22, 2014
T2CANDIDA AND T2DX INSTRUMENT
T2biosystems, Inc.
Microbiology
118d
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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.