# CJE: Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes

- Device class: 2; regulation: 21 CFR 862.1050; FDA's rule: 510(k) required
- FDA decisions: 124
- 510(k) review time 2021–2025: median 255 days (middle half 247–261)
- Recalls: 20 (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: 1
- 2011: 2
- 2012: 1
- 2013: 2
- 2017: 2
- 2018: 1
- 2019: 1
- 2023: 1
- 2024: 1
- 2025: 1

## Most-cited predicates
- K981897: Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas Integra Pancreatic a-Amylase Eps Reae (1998), cited by 3
- K171971: Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer (2018), cited by 2
- K033185: Cobas Integra Alp Ifcc Gen.2 (2003), cited by 2
- K023807: Modification to Alkp (2002), cited by 2
- K171080: ALP IFCC Gen.2 (2017), cited by 1
- K060205: General Chemistries on Abx Pentra 400 Clinical Chemistry Analyzer (2006), cited by 1
- K902560: Roche Cobas Ready Alkaline Phosphatase Reagent (1990), cited by 1
- K113436: Ace Alkaline Phosphatase Reagent, Ace Amylase Reagent, Ace LDH-L Reagent (2012), cited by 1
- K823213: Diagnostics Alkaline Phosphatase Optimi (1982), cited by 1
- K981806: ALKP (1998), cited by 1

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