# NQD: Cardiac C-Reactive Protein, Antigen, Antiserum, And Control

- Device class: 2; regulation: 21 CFR 866.5270; FDA's rule: 510(k) required
- FDA decisions: 19
- 510(k) review time 2021–2025: median 301 days (middle half 207–396)
- Recalls: 2 (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)
- 2004: 4
- 2005: 2
- 2006: 5
- 2007: 3
- 2008: 1
- 2018: 1
- 2022: 1
- 2024: 1
- 2026: 1

## Most-cited predicates
- K033908: N High Sensitivity CRP (2004), cited by 11
- K051564: Olympus CRP Latex Reagent, OSR6199; Olympus CRP Latex Calibrator Normal Set, ODC0026; Olympus CRP Latex  Calibrator High (2005), cited by 2
- K042485: Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) (2004), cited by 2
- K041799: Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products FS (2004), cited by 2
- K053603: C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments (2006), cited by 2
- K060369: Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak (2006), cited by 1
- K070626: Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent (2007), cited by 1
- K063057: Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP (2006), cited by 1
- K212559: CardioPhase® hsCRP (2022), cited by 1

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