# JHX: Fluorometric Method, Cpk Or Isoenzymes

- Device class: 2; regulation: 21 CFR 862.1215; FDA's rule: 510(k) required
- FDA decisions: 48
- 510(k) review time 2021–2025: median 109 days (middle half 84–133)
- Recalls: 11 (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)
- 2001: 2
- 2002: 1
- 2003: 1
- 2004: 3
- 2005: 1
- 2009: 1
- 2012: 1
- 2017: 1
- 2022: 1
- 2024: 1

## Most-cited predicates
- K973126: Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I (1997), cited by 5
- K981099: Stratus CS Stat Fluorometric Analyzer and Stratus CS CKMB Testpak (1998), cited by 2
- K000716: Access CK-MB on the Access Immunoassay Analyzer (2000), cited by 2
- K993068: Vitros Immunodiagnostic Products CK-MB Reagent Pack ; Vitros Immunodiagnostic Products CK-MB Calibrators (1999), cited by 1
- K004002: Immulite CK-MB, Model LKMB1 (100 Tests), LKMB5 (500 Tests); Immulite 2000 CK-MB, Model L2KMB2 (200 Tests), L2KMB6 (600) (2001), cited by 1
- K030012: CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372 (2003), cited by 1
- K984067: Stratus (R) CS Stat Fluorometric Analyzer, Stratus (R) CS CKMB Test Pak (1999), cited by 1
- K962549: Vidas Creatine Kinase MB Assay 30-421 (1996), cited by 1
- K120326: AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal Cartridge (2012), cited by 1
- K081360: Pathfast CK-MB-II, Pathfast Myo-II (2009), cited by 1

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