# CEC: Radioimmunoassay, Free Thyroxine

- Device class: 2; regulation: 21 CFR 862.1695; FDA's rule: 510(k) required
- FDA decisions: 92
- 510(k) review time 2021–2025: median 225 days (middle half 130–319)
- 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)
- 2009: 1
- 2012: 1
- 2013: 2
- 2014: 3
- 2015: 1
- 2016: 1
- 2017: 1
- 2018: 2
- 2023: 1
- 2024: 1

## Most-cited predicates
- K073604: Dimension Exl with LM Clinical Chemistry System, Dimension FT4L Flex Reagent Cartridge, and Loci Thyroid Calibrator, Mod (2008), cited by 4
- K961489: Elecsys FT4 Assay (1996), cited by 3
- K053531: Dimension Vista Free Thyroxine Flex Reagent Cartridge and Loci 1 Calibrator (2006), cited by 2
- K131244: Elecsys FT4 II Assay, Elecsys FT4 II Calset (2014), cited by 2
- K123379: Abbott Architect Free T4 (2012), cited by 2
- K080167: Acs 180 and Advia Centaur FT4 Immunoassays (2008), cited by 2
- K083373: Immulite 2000 Free T4 (2009), cited by 1
- K983417: Abbott Architect Free T4 (1998), cited by 1
- K902834: Abbott Imx Free T4 (1990), cited by 1
- K822882: Coat-a-Count Free Thyroxine Kit/Componen (1982), cited by 1

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