# JIT: Calibrator, Secondary

- Device class: 2; regulation: 21 CFR 862.1150; FDA's rule: 510(k) exempt
- FDA decisions: 245
- Recalls: 24 (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)
- 2008: 6
- 2009: 2
- 2010: 6
- 2011: 7
- 2012: 2
- 2013: 5
- 2014: 10
- 2015: 4
- 2016: 4
- 2017: 7

## Most-cited predicates
- K003501: N Protein Standard UY Calibrator (2001), cited by 4
- K003098: Access Ultrasensitive HGH Calibrators (2000), cited by 3
- K060854: Abx Pentra 400:  Lipoproteins (2006), cited by 3
- K152526: Elecsys Progesterone III CalSet (2015), cited by 2
- K983548: Ferritin Calibrator (1998), cited by 2
- K992981: Elecsys Estradiol Calset II (1999), cited by 2
- K021535: Advia Cantaur and Acs:180 Insulin Calibrator (2002), cited by 2
- K893139: Document (TM) Uric Acid Linearity Test Set (1989), cited by 2
- K981100: Stratus CS Trop Calpak (1998), cited by 2
- K983722: Stratus CS Troponin I Calibrator (1998), cited by 2

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