# NDY: Test, Cystatin C

- Device class: 2; regulation: 21 CFR 862.1225; FDA's rule: 510(k) required
- FDA decisions: 22
- 510(k) review time 2021–2025: median 259 days (middle half 259–259)
- Recalls: 1 (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)
- 2007: 3
- 2008: 6
- 2009: 1
- 2010: 3
- 2012: 1
- 2014: 1
- 2016: 1
- 2017: 1
- 2018: 1
- 2025: 1

## Most-cited predicates
- K003503: N Latex Cystatin C (2001), cited by 3
- K041878: N Latex Cystatin (2004), cited by 3
- K041627: Cystatin C Immunoparticles, Control Set, Calibrator (2004), cited by 3
- K093680: Diazyme Cystatin C Assay (2010), cited by 2
- K141143: Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C Gen.2 Control Set (2014), cited by 2
- K161817: Tina-quant Cystatin C Gen.2 (2016), cited by 1
- K071388: Gentian Cystatin C Immunoassay (2007), cited by 1
- K171072: N Latex Cystatin C; N Protein Standard UY (2017), cited by 1
- K080811: Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control Set (2008), cited by 1

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