# K063864: Qwikcheck Test Strips- Reagent Strips for Semen Analysis

- Pathway: 510(k) (Traditional)
- Applicant: Medical Electronic Systems, Ltd.
- Decided: Mar 26, 2007 after 87 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
QWwikCheck™ Test Strips are for in vitro diagnostic use for the determination of pH and leukocytes (WBCs) in semen. Test results are determined by comparing the color of the test patches to the color chart provided on the bottle label. The test is for professional use only.

Source page: https://510kreport.com/device/K063864
Methodology: https://510kreport.com/methodology