Not Cleared Post-NSE

GLUCATELL (DEN040003) - FDA 510(k) Clearance

Class II Microbiology device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

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

DEN040003 is an FDA 510(k) submission (not cleared) for the GLUCATELL. Classified as Antigen, Invasive Fungal Pathogens (product code NQZ), Class II - Special Controls.

Submitted by Associates of Cape Cod, Inc. (Woodbury, US). The FDA issued a Not Cleared (DENG) decision on May 21, 2004 after a review of 60 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3050 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

View all Associates of Cape Cod, Inc. devices

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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 102d · This submission: 60d
Pathway characteristics

Device Classification

Product Code NQZ Antigen, Invasive Fungal Pathogens
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.