Product code PII— Microbiology

“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.”

FDA has cleared 3 devices under product code PII between 2014 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20241 clearance
• 20171 clearance
• 20141 clearance

• T2biosystems, Inc.3 clearances

• K234063 — T2Candida 1.1 PanelT2biosystems, Inc.·2024-09-13
• K173536 — T2Candida 1.1 PanelT2biosystems, Inc.·2017-12-12
• DEN140019 — T2CANDIDA AND T2DX INSTRUMENTT2biosystems, Inc.·2014-09-22