# K243496: MycoMEIA Aspergillus Assay

- Pathway: 510(k) (Traditional)
- Applicant: Pearl Diagnostics, Inc.
- Decided: Aug 1, 2025 after 262 days
- Product code: NOM (Antigen, Galactomannan, Aspergillus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K023857 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093678: Platelia Aspergillus Eia Model 62793, Bio-Rad (2011) Summary page 5.

## Indications for use
The MycoMEIA Aspergillus Assay (MycoMEIA) is an enzyme immunoassay (EIA) for the in vitro qualitative detection of Aspergillus antigens in human urine from adults (>/= 18 years old) with suspected invasive aspergillosis (IA). The assay is not intended for use in lung transplant recipients. The results should be interpreted by trained healthcare professionals, incorporating other diagnostic procedures such as microbiological culture, histological examination of biopsy samples, and radiographic evidence to support the diagnosis of IA.

Source page: https://510kreport.com/device/K243496
Methodology: https://510kreport.com/methodology