# K071737: General Semen Analysis Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dyn-Bioshaf (2006), Ltd.
- Decided: Oct 25, 2007 after 121 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
The GSA kit is for the evaluation of human semen and provides a set of reagents to evaluate semen quality by measuring five parameters, recommended by the World Health Organization (WHO), that are used to determine whether infertility is caused by abnormalities of one or more of them. The parameters include: Sperm Count, sperm motility, sperm viability, white blood cell (WBC) count, and Sperm head morphology (the subject of this 510(k) submission.

Source page: https://510kreport.com/device/K071737
Methodology: https://510kreport.com/methodology