# DHX: System, Test, Carcinoembryonic Antigen

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 29
- 510(k) review time 2021–2025: median 179 days (middle half 134–223)
- Recalls: 6 (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)
- 1998: 4
- 1999: 3
- 2001: 1
- 2002: 1
- 2003: 1
- 2004: 1
- 2008: 2
- 2009: 1
- 2020: 1
- 2023: 2

## Most-cited predicates
- K981985: Access Cea Reagents on the Access Immunoassay Analyzer Model 33200, 33205, 33206 & 33209 (1998), cited by 3
- K990774: Abbott Architect Cea (1999), cited by 2
- K991707: Modification to Access Cea Reagents for Use on the Access Immunoassay Analyzer, Models 33200, 33205, 33209, 33206 (1999), cited by 2
- K071603: Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea) (2008), cited by 1
- K041322: Vitros Immunodiagnostic Products Cea Reagent Pack/Calibrator/Range Verifiers (2004), cited by 1
- K031270: Access Cea Reagents for Use on the Access Immunoassay Systems (2003), cited by 1
- K981478: Acs:Centaur Cea (1998), cited by 1
- K990943: Vitros Immunodiagnostic Products Cea Calibrators, Vitros Immunodiagnostic Products Cea Reagent Pack (1999), cited by 1
- K023893: ST Aia-Pack Cea Enzyme Immunoassay (2002), cited by 1

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