510(k) K243496
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 1, 2025
- Date Received
- November 12, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Galactomannan, Aspergillus Spp.
- Device Class
- Class I
- Regulation Number
- 866.3040
- Review Panel
- MI
- Submission Type
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.