K243496 is an FDA 510(k) clearance for the MycoMEIA Aspergillus Assay. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3040. 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..
| 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 |
| 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. |