# K032874: Hba Sperm-Hyaluronan Binding Assay

- Pathway: 510(k) (Traditional)
- Applicant: Biocoat, Inc.
- Decided: Nov 24, 2003 after 70 days
- Product code: POV (Semen Analysis Device)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
1. As a component of the standard analysis of semen in the diagnosis of suspected male infertility, 2. As a component of analyses for determining the proper course of IVF treatment of infertility.

Source page: https://510kreport.com/device/K032874
Methodology: https://510kreport.com/methodology