# K041240: Semen Analysis Quality Control, Assayed and Unassayed

- Pathway: 510(k) (Traditional)
- Applicant: Fertility Solutions, Inc.
- Decided: Jun 2, 2004 after 22 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
Longest line of descent: 2 generations back to K896154 (1989). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993825: Para Tech Plus Retics, Streck Laboratories, Inc. (1999) Summary page 2.
- K010598: Synovialscopics, Synovial Fluid Control, Quantimetrix Corp. (2001) Summary page 2.
- K020229: R & D Body Fluid Control, R&D Systems, Inc. (2002) Summary page 2.
- K010409: CBC-SF, R&D Systems, Inc. (2001) Summary page 2.

## Indications for use
The AQCTM Sperm Count and AQCTM Post-vasectomy Quality Controls are intended for monitoring sperm counts performed either manually using commercially available counting chambers or using computer assisted semen analysis (CASA) instruments. The AQCTM Sperm Count and AQCTM Post-vasectomy Quality Controls are intended for use as Quality Control materials having known sperm concentrations. Daily monitoring of the control values establishes intralaboratory parameters for accuracy and precision of the cell counting methods. These products are also available for external laboratory quality control and proficiency testing and as such are sold under the proprietary trade names, AQCTM Sperm Count and AQCTM Post-Vasectomy Proficiency Challenges.

Source page: https://510kreport.com/device/K041240
Methodology: https://510kreport.com/methodology