# JJY: Multi-Analyte Controls, All Kinds (Assayed)

- Device class: 1; regulation: 21 CFR 862.1660; FDA's rule: 510(k) exempt
- FDA decisions: 673
- Recalls: 52 (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: 7
- 2009: 8
- 2010: 10
- 2011: 14
- 2012: 13
- 2013: 16
- 2014: 10
- 2015: 4
- 2016: 1
- 2017: 3

## Most-cited predicates
- K950469: Document Serum Multianalyte Calibration Verification Test Set (1995), cited by 18
- K041227: Modification to:Roche Diagnostics Precinorm Universal and Precipath Universal Control Sera (2004), cited by 16
- K012468: Modification to N/T Protein Control SL (2001), cited by 14
- K042318: Audit Microcv General Chemistry Linearity Set (2004), cited by 12
- K973517: Vitros Immunodiagnostic Products Range Verifiers (1997), cited by 8
- K020817: Liquichek Urine Chemistry Control (2002), cited by 6
- K981532: Lyphochek Immunoassay Plus Control (1998), cited by 6
- K050537: Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus (2005), cited by 6
- K001373: Liquichek Immunoassay Plus Control, Model 360, 361, 362, 363 (2000), cited by 5
- K012513: Liquichek Lipids Control Level 1, Liquichek Lipids Control Level 2, Models 641 and 642 (2001), cited by 4

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