510(k) · Cleared
ClearedAccess CK-MB on the Access Immunoassay Analyzer, Models 33300, 33305, 33309, 33306
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JHX Fluorometric Method, Cpk Or Isoenzymes
Cleared on Jan 14, 2000 after a 22-day review. The FDA summary names no predicate by number.
- Decided
- Jan 14, 2000
- Review
- 22 days
- Class
- Class II
- Product code
- JHX
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JHX device
- #1 K234005 Access CK-MBscore 7.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JHX devicesJHX Fluorometric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHX
Too few JHX 510(k)s in any year since 2007 to give a median.
Recalls per year · JHX
2in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHX
1in 2025
MAUDE reports naming product code JHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 1 | 6 |
| 2009 | 1 | — | 1 | 40 |
| 2010 | 0 | — | 0 | 27 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 1 | — | 4 | 18 |
| 2013 | 0 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 17 |
| 2015 | 0 | — | 2 | 8 |
| 2016 | 0 | — | 0 | 10 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 3 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 1 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The AcCEss® CK-MB assay is a paramagnetic-particle, chemiluminescent immunoassay for the quantitative determination of CK-MB levels in human serum or plasma, using the Access Immunoassay System. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994439: Access CK-MB on the Access Immunoassay Analyzer, Models 33300, 33305, 33309, 33306.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994439
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026