510(k) · Cleared
ClearedCK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372
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 17, 2003 as substantially equivalent to K000716 (Beckman Coulter, Inc., 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Jan 17, 2003
- Review
- 15 days
- Class
- Class II
- Product code
- JHX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000716 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK000716 Access CK-MB on the Access Immunoassay AnalyzerBeckman Coulter, Inc. · 2000
- This deviceK030012 CK-MB and CK-MB Calibrators on the Access Immunoassay Systems…Beckman Coulter, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK234005 Access CK-MBBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K234005Access CK-MBBeckman Coulter, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000716 | Access CK-MB on the Access Immunoassay Analyzer | Beckman Coulter, Inc. | 2000 | — |
| 0 (this device) | K030012 | CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371… | Beckman Coulter, Inc. | 2003 | — |
| +1 | K234005 | Access CK-MB | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000716 | Access CK-MB on the Access Immunoassay Analyzer | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K234005 | Access CK-MB | 2024 | 0 |
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.
What does this lineage say?
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 and plasma using the Access Immunoassay Systems. Measurement of creatine kinase is used in the diagnosis and treatment of myocardial infarction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030012 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030012: CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030012
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026