# K023857: Platelia Aspergillus Eia, Models 62793 and 62794

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: May 16, 2003 after 177 days
- Product code: NOM (Antigen, Galactomannan, Aspergillus Spp.)
- Device class: 1
- Regulation: 21 CFR 866.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) Meridian Premier Cryptococcal Antigen: named in the summary without a submission number

## Most influential descendants
- K060641: Platelia Aspergillus Eia, Model 62793 (2006), 3 descendants of its own
- 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

## Recalls of this device
- Nov 6, 2003 · Not classified · Z-0348-04: Potential drug and device interaction with piperacillin/tazobactam (Zosyn) causing positive test result for galactomannan.

## Indications for use
The PlateliaB Aspergillus EIA is an immunoenzymatic sandwich microplate assay for the detection of Aspergillus galactomannan antigen in serum. The PlateliaB 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/K023857
Methodology: https://510kreport.com/methodology