# JIS: Calibrator, Primary

- Device class: 2; regulation: 21 CFR 862.1150; FDA's rule: 510(k) exempt
- FDA decisions: 130
- Recalls: 14 (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)
- 1997: 1
- 1998: 1
- 1999: 2
- 2000: 11
- 2001: 6
- 2002: 2
- 2003: 6
- 2005: 1
- 2006: 2
- 2012: 1

## Most-cited predicates
- K030964: Calibration Plasma LMW Heparin (2003), cited by 3
- K994114: Dimension Total Iron Binding Capacity (Ibct) Calibrator (2000), cited by 2
- K022682: Randox C-Reactive Protein Calibrator (2002), cited by 2
- K951964: Synchron Enzyme Validator Set (1995), cited by 1
- K931834: King Sodium/Potassium Standard Modified (1993), cited by 1
- K011568: Randox Lipoprotein (2001), cited by 1
- K003969: Elecsys CA 125 II Calset (2001), cited by 1
- K870379: Ise Compensation Sera (1987), cited by 1
- K944701: Calibrators (1994), cited by 1
- K032697: Dimension Total Triiodothyronine Calibrator (RC414) (2003), cited by 1

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