# K093678: Platelia Aspergillus Eia Model 62793

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jan 13, 2011 after 412 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: 2 generations back to K023857 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060641: Platelia Aspergillus Eia, Model 62793, Bio-Rad (2006) Summary page 3.

## Most influential descendants
- K243496: MycoMEIA Aspergillus Assay (2025), 0 descendants of its own

## Indications for use
The Platelia Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric serum and Bronchoalveolar lavage (BAL) fluid samples. The Platelia Aspergillus EIA 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.

Source page: https://510kreport.com/device/K093678
Methodology: https://510kreport.com/methodology