# K041866: Abbott Axsym Testosterone Microparticle Enzyme Immunoassay (Meia)

- Pathway: 510(k) (Traditional)
- Applicant: Axis-Shield Diagnostics, Ltd.
- Decided: Sep 29, 2004 after 82 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K964889 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964889: Elecsys Testosterone Assay, Boehringer Mannheim Corp. (1997) Summary page 1.

## Indications for use
AxSYM® Testosterone is a Microparticle Enzyme Ihmunoassay (MEIA) for the quantitative determination of testosterone in human serum and plasma on the AxSYM System. Testosterone monitoring is used clinically to diagnose and differentiate endocrine disorders. In males, these include hypogonadism, testicular failure, infertility, hypopituitarism and hyperprolactinemia. In females, polycystic ovary syndrome, adrenal hyperplasia, infertility, hirsutism, amenorrhea, obesity and virilization can cause changes in serum testosterone levels. The AxSYM® Testosterone assay is used as an aid in the investigation of infertility in males and of hirsutism and virilization in females. The AxSYM® Testosterone Standard Calibrators are for the standard calibration of the AxSYM system when used for the quantitative determination of testosterone in human serum and plasma.

Source page: https://510kreport.com/device/K041866
Methodology: https://510kreport.com/methodology