# DAP: Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 864.7320; FDA's rule: 510(k) required
- FDA decisions: 58
- Recalls: 9 (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)
- 2008: 3
- 2009: 1
- 2010: 2
- 2011: 1
- 2012: 1
- 2014: 1
- 2015: 1
- 2016: 2
- 2017: 1
- 2026: 1

## Most-cited predicates
- K040882: Vidas D-Dimer Exclusion Assay, Model 30 442 (2004), cited by 9
- K972696: IL Test D-Dimer (1997), cited by 5
- K070927: Hemosil D-Dimer HS (2007), cited by 4
- K002706: Roche Diagnostics Tina-Quant D-Dimer on Cobas Integra; Roche Diagnostics Tina-Quant D-Dimer on Hitachi (2001), cited by 3
- K022976: Stratus CS D-Dimer (DDMR) Method (Testpak & Dilpak), Models Cddmr & Cddmr-D (2003), cited by 3
- K862156: Asserachrom D-DI Kit (1986), cited by 3
- K040437: Triage Profiler S.O.B. Panel (2004), cited by 2
- K093626: Innovance D-Dimer, Model OPBP09 (2010), cited by 2
- K992957: Advanced D-Dimer (2000), cited by 2
- K020810: Vidas D-Dimer New (DD2) Assay Model#30 442 (2002), cited by 2

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