# LTK: Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125)

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 26
- 510(k) review time 2021–2025: median 216 days (middle half 148–446)
- Recalls: 10 (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)
- 2003: 1
- 2004: 1
- 2007: 1
- 2009: 2
- 2011: 1
- 2015: 2
- 2020: 1
- 2022: 1
- 2023: 1
- 2024: 1

## Most-cited predicates
- K972162: Elecsys CA 125 II (1998), cited by 3
- K020828: CA 125 Assay for the Advia Centaur System (2002), cited by 3
- K023597: Access OV Monitor Immunoenzymetric Assay (2002), cited by 2
- K981297: Immulite OM-MA, Models Lkopz, LKOP1, LKOP5 (1998), cited by 2
- K983391: Immulite 2000 OM-MA Model L2KOP2 (1998), cited by 2
- K983715: The Immuno 1 CA 125 II Assay for the Bayer Immuno 1 System (in Vitro Diagnostic System) (1999), cited by 1
- K964020: Axsym CA 125 (1997), cited by 1
- K990431: Aia-Pack CA 125 (1999), cited by 1
- K042731: Architect CA 125 II Assay (2004), cited by 1
- K023891: ST Aia-Pack CA 125 Enzyme Immunoassay (2002), cited by 1

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