# K060641: Platelia Aspergillus Eia, Model 62793

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Jun 2, 2006 after 84 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: 1 generation back to K023857 (2003). 1 ancestor in all.
3 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023857: Platelia Aspergillus Eia, Models 62793 and 62794, Bio-Rad (2003) Summary page 2.

## Most influential descendants
- K093678: Platelia Aspergillus Eia Model 62793 (2011), 1 descendant of its own
- K243496: MycoMEIA Aspergillus Assay (2025), 0 descendants of its own
- K101407: Alpha Histoplasma Antigen Eia Model HAG102 (2011), 0 descendants of its own

## Indications for use
The PlateliaTM Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in adult and pediatric serum samples. The PlateliaTM 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/K060641
Methodology: https://510kreport.com/methodology