# K024337: General Semen Analysis (Gsa) Kit

- Pathway: 510(k) (Traditional)
- Applicant: Bioshaf, Ltd.
- Decided: Jul 3, 2003 after 188 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. The FDA summary names no predicate by number.

## Indications for use
The GSA Kit is for the evaluation of human semen. The kit provides the user with a set of reagents used to evaluate semen quality by measuring four (4) 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 vitality White blood cell (WBC) count In most fertility test laboratorics these parameters are manually evaluated on a routine basis using a light microscope and a counting chamber. The performance characteristics of the GSA kit is based on a comparison between the GSA kit and the routine manual method performed according to the latest edition of the Manual for the Examination of Human Semen and Sperm published by the WHO.

Source page: https://510kreport.com/device/K024337
Methodology: https://510kreport.com/methodology