Cleared Traditional

MycoMEIA Aspergillus Assay

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

About This 510(k) Submission

K243496 is an FDA 510(k) clearance for the MycoMEIA Aspergillus Assay, a Antigen, Galactomannan, Aspergillus Spp. (Class I — General Controls, product code NOM), submitted by Pearl Diagnostics, Inc. (Baltimore, US). The FDA issued a Cleared decision on August 1, 2025, 262 days after receiving the submission on November 12, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3040.

Submission Details

510(k) Number K243496 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NOM — Antigen, Galactomannan, Aspergillus Spp.
Device Class Class I — 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.