# MOI: System, Test, Immunological, Antigen, Tumor

- Device class: 2; regulation: 21 CFR 866.6010; FDA's rule: 510(k) required
- FDA decisions: 28
- 510(k) review time 2021–2025: median 90 days (middle half 90–90)
- Recalls: 7 (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)
- 2000: 1
- 2001: 2
- 2002: 3
- 2004: 2
- 2007: 1
- 2011: 1
- 2018: 2
- 2019: 1
- 2020: 2
- 2024: 2

## Most-cited predicates
- K971418: Chiron Diagnostics Automated Chemiluminescence System (Asc) Centaur Analyzer (1997), cited by 2
- K012357: CA 15-3 Assay for the Advia Centaur System (2002), cited by 2
- K072612: Access Immunoassay Systems BR Monitor, and Calibrators, Model (S) 387620,and 387647 (2007), cited by 2
- K033036: BR Monitor and BR Monitor Calibrators on the Access Immunoassay Systems, Model 387620, 387647 (2004), cited by 2
- K964703: The CA 15-3 Assay for the Technicon Immuno 1 System (in Vitro Diagnostic System) (1997), cited by 2
- K963926: Axsym CA 15-3 (1997), cited by 2
- K001468: Elecsys CA 15-3 Test System (2000), cited by 1
- K981698: Acs:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29) (1998), cited by 1
- K100344: Dimension Vista Loci CA 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator, Models: K6456 and KC605 (2011), cited by 1
- K042732: Architect CA 15-3 Assay (2004), cited by 1

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