Cleared Traditional

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

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191167 · Associates of Cape Cod, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
77d
Days
Class 2
Risk

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

Submitted by Associates of Cape Cod, Inc. (East Falmouth, US). The FDA issued a Cleared decision on July 17, 2019 after a review of 77 days - a notably fast clearance cycle.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Associates of Cape Cod, Inc. devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.