# DDG: Transferrin, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5880; FDA's rule: 510(k) required
- FDA decisions: 48
- 510(k) review time 2021–2025: median 84 days (middle half 84–84)
- Recalls: 3 (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: 5
- 2004: 1
- 2006: 1
- 2007: 4
- 2008: 2
- 2013: 1
- 2018: 1
- 2020: 1
- 2024: 1

## Most-cited predicates
- K926272: Beckman Transferrin Kit (1993), cited by 4
- K053075: N Antisera to Human Transferrin (2006), cited by 3
- K063663: Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H (2007), cited by 2
- K012393: Tina-Quant Transferrin Ver.2 (2001), cited by 2
- K042477: Vitros Chemistry Products Trfrn Reahent; Vitros Chemistry Products Calibrator Kit 20; Vitros Chemistry Products Protein (2004), cited by 1
- K933589: Boehringer Mannheim Tina-Quant Transferrin Assay (1993), cited by 1
- K972840: N Antiserum to Human Transferrin (1997), cited by 1
- K963427: Immage Immunochemistry System Transferrin (TRF) Reagent (1996), cited by 1
- K080634: Access STFR, Access STFR Calibrators, and Access STFR QC with Models, A32493, A32494, and A32495 (2008), cited by 1

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