# JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

- Device class: 1; regulation: 21 CFR 862.1660; FDA's rule: 510(k) exempt
- FDA decisions: 493
- Recalls: 19 (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: 8
- 2009: 17
- 2010: 24
- 2011: 19
- 2012: 15
- 2013: 19
- 2014: 22
- 2015: 11
- 2016: 6
- 2017: 2

## Most-cited predicates
- K924862: Aia-Pack HCG Calibration Verification Test Set (1992), cited by 9
- K963147: Elecsys Calcheck TSH (1996), cited by 8
- K133128: Immulite 2000; HCG Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-D Calibration (2013), cited by 7
- K092168: Elecsys HCG+B Calcheck 5 (2009), cited by 6
- K040157: Elecsys C-Peptide Calcheck (2004), cited by 6
- K100810: Elecsys  C-Peptide Calcheck 5 (2010), cited by 6
- K140258: Immulite 2000 Dhea-SO4; Third Generation TSH and Intact PTH Calibration Verification Material (2014), cited by 6
- K052980: Liberty Glucose Control, Model 2120031 (2005), cited by 5
- K924863: Aia-Pack FSH Calibration Verification Test Set (1992), cited by 5
- K062501: Validate Thyroid Calibration Verification / Linearity Test Set, Model 901 (2006), cited by 5

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