# K223405: Access Testosterone

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter, Inc.
- Decided: Jan 13, 2023 after 65 days
- Product code: CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone)
- Device class: 1
- Regulation: 21 CFR 862.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001935 (2000). 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)
- K001935: Access Testosterone Reagents for Use on the Access Immunoassay Analyzer, Models 33560, 33565, Beckman Coulter, Inc. (2000) Summary page 4.

## Recalls of this device
- May 5, 2025 · Class II · Z-1901-2025: Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could p

## Indications for use
The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Source page: https://510kreport.com/device/K223405
Methodology: https://510kreport.com/methodology