Product code NQZ— Microbiology

“Invasive fungal pathogen assays are devices that consist of antigens, antisera, or proteases used in serological assays for the presumptive diagnosis of fungal infection in serum or plasma. The assay is indicated for use in patients with symptoms of, or medical conditions predisposing the patient to invasive fungal infection. The device can be used as an aid in the diagnosis of deep seated mycoses and fungemias. A positive result does not indicate which class of fungi may be causing infection. The assays should be used in conjunction with other diagnostic procedures, such as microbiological culture, histological examination of biopsy samples and radiological examination.”

FDA has cleared 2 devices under product code NQZ between 2004 and 2019, 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.

• 20191 clearance
• 20041 clearance

• Associates of Cape Cod, Inc.2 clearances

• K191167 — Fungitell STATAssociates of Cape Cod, Inc.·2019-07-17
• DEN040003 — GLUCATELLAssociates of Cape Cod, Inc.·2004-05-21