# JIX: Calibrator, Multi-Analyte Mixture

- Device class: 2; regulation: 21 CFR 862.1150; FDA's rule: 510(k) exempt
- FDA decisions: 302
- Recalls: 41 (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: 6
- 2008: 5
- 2009: 4
- 2010: 5
- 2011: 7
- 2012: 2
- 2013: 4
- 2014: 1
- 2015: 3
- 2016: 1

## Most-cited predicates
- K033501: Modification to Calibrator for Automatic Systems (Cfas) (2003), cited by 17
- K012470: Modification to N Protein Standard SL (2001), cited by 16
- K930104: Ace Clinical Chemistry System (1993), cited by 7
- K990460: Calibrator for Automated Systems (C.F.a.S.) (1999), cited by 5
- K011035: Dimension Drug Calibrator, Model DC22B (2001), cited by 5
- K964527: N Rheumatology Standard SL (1997), cited by 4
- K041905: Hemosil Calibration Plasma (2004), cited by 3
- K902675: Multi Analyte Mixture, Calibrators (1990), cited by 2
- K062334: Dimension Vista Chemistry 3 Calibrator, Model KC130 (2006), cited by 2
- K875285: Multi-Chemistry Linearity Standard (1988), cited by 2

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