Not Cleared Post-NSE

DEN040003 - GLUCATELL (FDA 510(k) Clearance)

DEN040003 · Associates of Cape Cod, Inc. · Microbiology device
May 2004
Decision
60d
Days
Class 2
Risk

DEN040003 is an FDA 510(k) submission for the GLUCATELL. This device is classified as a Antigen, Invasive Fungal Pathogens (Class II - Special Controls, product code NQZ).

Submitted by Associates of Cape Cod, Inc. (Woodbury, US). The FDA issued a Not Cleared (DENG) decision on May 21, 2004.

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 DEN040003 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 22, 2004
Decision Date May 21, 2004
Days to Decision 60 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -

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.