Cleared Traditional

K191167 - Fungitell STAT (FDA 510(k) Clearance)

K191167 · Associates of Cape Cod, Inc. · Microbiology device
Jul 2019
Decision
77d
Days
Class 2
Risk

K191167 is an FDA 510(k) clearance for the Fungitell STAT. This device is classified as a Antigen, Invasive Fungal Pathogens (Class II - Special Controls, product code NQZ).

Submitted by Associates of Cape Cod, Inc. (East Falmouth, US). The FDA issued a Cleared decision on July 17, 2019, 77 days after receiving the submission on May 1, 2019.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3050. 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..

Submission Details

510(k) Number K191167 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2019
Decision Date July 17, 2019
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code NQZ - Antigen, Invasive Fungal Pathogens
Device Class Class II - Special Controls
CFR Regulation 21 CFR 866.3050
Definition 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.