# K041600: Qwikcheck-Beads

- Pathway: 510(k) (Traditional)
- Applicant: Medical Electronics Systems, Ltd.
- Decided: Jul 27, 2004 after 43 days
- Product code: NRF (Material, Quality Control, Semen Analysis)
- Device class: 2
- Regulation: 21 CFR 864.8625
- 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
QwikCheck-beadsTM is intended for in-vitro diagnostic use as sperm concentration quality control material for the SQA-V system (MES Ltd., Israel) in both the automated and manual visualization modes, as well as non-instrumented sperm cell counting chambers such as the hemacytometer (Neubauer type), and the non-dilutional chamber (Makler type).

Source page: https://510kreport.com/device/K041600
Methodology: https://510kreport.com/methodology