# K101407: Alpha Histoplasma Antigen Eia Model HAG102

- Pathway: 510(k) (Traditional)
- Applicant: Immuno-Mycologics, Inc.
- Decided: Jul 19, 2011 after 426 days
- Product code: MIZ (Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum)
- Device class: 2
- Regulation: 21 CFR 866.3320
- 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.
No later device cites it as a predicate yet.
0 of 3 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 1.

## Indications for use
The ALPHA Histoplasma Antigen EIA is an immunoenzymatic sandwich microplate assay for the detection of Histoplosma antigens in urine samples. The ALPHA Histaplasma Antigen 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 histoplasmosis.

Source page: https://510kreport.com/device/K101407
Methodology: https://510kreport.com/methodology