Cleared Traditional

K243496 - MycoMEIA Aspergillus Assay (FDA 510(k) Clearance)

Class I Microbiology device.

K243496 · Pearl Diagnostics, Inc. · Microbiology device
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Aug 2025
Decision
262d
Days
Class 1
Risk

K243496 is an FDA 510(k) clearance for the MycoMEIA Aspergillus Assay. Classified as Antigen, Galactomannan, Aspergillus Spp. (product code NOM), Class I - General Controls.

Submitted by Pearl Diagnostics, Inc. (Baltimore, US). The FDA issued a Cleared decision on August 1, 2025 after a review of 262 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3040 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pearl Diagnostics, Inc. devices

Submission Details

510(k) Number K243496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2024
Decision Date August 01, 2025
Days to Decision 262 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
160d slower than avg
Panel avg: 102d · This submission: 262d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NOM Antigen, Galactomannan, Aspergillus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3040
Definition The Platelia Aspergillus Eia Is An Immunoenzymatic Sandwich Microplate Assay For The Detection Of Aspergillus Galactomannan Antigen In Human Serum. It Is A Test Which, When Used In Conjunction With Other Diagnostic Procedures Such As Microbiological Culture, Histological Examination Of Biopsy Samples And Radiographic Evidence, Can Be Used As An Aid In The Diagnosis Of Invasive Aspergillosis.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.