# K042750: QC-Beads

- Pathway: 510(k) (Traditional)
- Applicant: Bioscreen, Inc.
- Decided: Oct 29, 2004 after 25 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
QC-BeadsTm are intended for use as controls in counting sperm manually using a microscope or automatically using computer assisted semen analysis instruments.

Source page: https://510kreport.com/device/K042750
Methodology: https://510kreport.com/methodology