# CDZ: Radioimmunoassay, Testosterones And Dihydrotestosterone

- Device class: 1; regulation: 21 CFR 862.1680; FDA's rule: 510(k) required
- FDA decisions: 89
- 510(k) review time 2021–2025: median 157 days (middle half 95–241)
- Recalls: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2014: 1
- 2015: 2
- 2016: 4
- 2018: 1
- 2019: 4
- 2020: 1
- 2022: 1
- 2023: 1
- 2024: 2
- 2026: 1

## Most-cited predicates
- K093421: Elecsys Testosterone II Immunoassay (2010), cited by 5
- K964889: Elecsys Testosterone Assay (1997), cited by 3
- K844423: Coat-a-Count Free Testosterone Kit & Components (1985), cited by 2
- K120009: Testosterone Test System; Calibrator; and Quality Control Material (Assayed and Unassayed) (2012), cited by 2
- K941797: Immulite SHBG (1994), cited by 2
- K031717: Elecsys SHBG Immunoassay (2003), cited by 2
- K151986: ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material (2016), cited by 2
- K831342: Coat-a-Count NO-Extraction Testosterone (1983), cited by 2
- K060818: Architect SHBG Reagent Kit, Architect SHBG Calibrator Kit, and Architect SHBG Control Kit with Models, 8K26-25, 8K26-01 (2007), cited by 2
- K813401: Coat-a-Count Testosterone Ria Kit (1981), cited by 2

Source page: https://510kreport.com/product-code/CDZ
Data by year (CSV): https://510kreport.com/product-code/CDZ.csv