# JJT: Enzyme Controls (Assayed And Unassayed)

- Device class: 1; regulation: 21 CFR 862.1660; FDA's rule: 510(k) exempt
- FDA decisions: 97
- Recalls: 2 (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)
- 1995: 5
- 1996: 3
- 1997: 9
- 1998: 3
- 1999: 4
- 2001: 1
- 2002: 1
- 2003: 2
- 2006: 1
- 2009: 1

## Most-cited predicates
- K961828: Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) (1996), cited by 6
- K903430: Liquichek CK/LD Isoenzyme Control; Levels 1 and 2 (1990), cited by 2
- K971777: Quantex Aso-CRP-RF Control (1997), cited by 1
- K012656: Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 (2001), cited by 1
- K021498: Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel (2002), cited by 1
- K974461: Triage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB Control, Triage Myoglobin Control (1997), cited by 1
- K950803: Isolab's Galactose-1-Phosphate Uridyl Tranferase Test Kits 800, 4000 Sample (1995), cited by 1
- K960246: Liquid Cardiac Marker 1,2,3 Assayed (1996), cited by 1
- K980556: Liquichek Cardiac Markers Control LT (1998), cited by 1

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