# CEW: Radioimmunoassay, Parathyroid Hormone

- Device class: 2; regulation: 21 CFR 862.1545; FDA's rule: 510(k) required
- FDA decisions: 86
- 510(k) review time 2021–2025: median 266 days (middle half 219–382)
- Recalls: 17 (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)
- 2007: 4
- 2010: 1
- 2012: 1
- 2013: 2
- 2014: 1
- 2015: 1
- 2017: 2
- 2019: 1
- 2023: 1
- 2024: 2

## Most-cited predicates
- K992680: Elecsys Parathyroid Hormone Test System (1999), cited by 5
- K033426: Liaison N-Tact PTH (2004), cited by 3
- K070709: Roche Elecsys PTH Test System (2007), cited by 2
- K013992: Nichols Advantage Chemiluminescence Bio-Intact Parathyroid Hormone (1-84) Immunoassay (2001), cited by 2
- K954418: Intact Parathyroid Hormone (PTH) Immunoassay (Modification) (1995), cited by 2
- K133601: Advia Centaur Intact Parathyroid Hormone (Ipth) Assay (2014), cited by 1
- K022603: Immulite 1000 Automated Immunoassay Analyzer (2002), cited by 1
- K150879: LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers (2015), cited by 1
- K011505: Immulite Intact PTH, Model LKPP1 (100 Tests), LKPP5 (500 Tests), Immulite 2000 Intact PTH, Model L2KPP (200 Tests), L2K6 (2001), cited by 1
- K962598: Nichols Advantage Chemiluminescence Intact Parathyroid Hormone Kit (1996), cited by 1

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