# DDR: Myoglobin, Antigen, Antiserum, Control

- Device class: 2; regulation: 21 CFR 866.5680; FDA's rule: 510(k) required
- FDA decisions: 46
- 510(k) review time 2021–2025: median 88 days (middle half 88–88)
- Recalls: 8 (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)
- 2001: 2
- 2002: 1
- 2003: 1
- 2004: 1
- 2005: 1
- 2006: 1
- 2009: 2
- 2012: 1
- 2013: 1
- 2023: 1

## Most-cited predicates
- K902154: NA Latex Myoglobin Test (1990), cited by 4
- K974325: Chiron Diagnostics Acs:180 Myoglobin (1997), cited by 3
- K021229: Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243, 973244 (2002), cited by 3
- K981102: Stratus CS Myoglobin (Myo) Testpak (1998), cited by 2
- K984191: Myoglobin Flex Reagent Cartridge (1998), cited by 2
- K972513: Tinaquant Myoglobin Assay (1997), cited by 2
- K042924: Architect Stat Myo Immunoassay (2005), cited by 2
- K000196: Access Myoglobin on the Access Immunoassay Analyzer, Models 33310, 33315, 33319, 33316 (2000), cited by 2
- K983176: Elecsys Myoglobin Stat Assay (1998), cited by 1
- K984065: Stratus (R) CS Myoglobin (Myo) Testpak (1998), cited by 1

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