# JFJ: Catalytic Methods, Amylase

- Device class: 2; regulation: 21 CFR 862.1070; FDA's rule: 510(k) required
- FDA decisions: 99
- 510(k) review time 2021–2025: median 449 days (middle half 449–449)
- Recalls: 1 (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)
- 2002: 3
- 2004: 2
- 2006: 2
- 2007: 1
- 2008: 1
- 2009: 1
- 2012: 1
- 2013: 1
- 2019: 2
- 2022: 1

## Most-cited predicates
- K972250: Roche Cobas Integra Reagent Cassettes & Ancillary Reagents (1997), cited by 6
- K903309: Roche Cobas Ready Amylase Reagent (1990), cited by 2
- K981653: AMY (1998), cited by 1
- K801295: Cobas Reagent for a-Amylase (1980), cited by 1
- K972297: Amylase-Incorporating Dynamic Stabilization Technology - (DST) (1997), cited by 1
- K070064: Amylase Eps Reagent (2007), cited by 1
- K934293: Beckman Pancreatic Amylase (Pamy) Reagent (1994), cited by 1
- K942640: Dupont Dimension Amylase Method (1994), cited by 1

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