510(k) · Cleared
ClearedVidas Creatine Kinase MB Assay 30-421
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomerieux Vitek, Inc. · JHX Fluorometric Method, Cpk Or Isoenzymes
Cleared on Aug 30, 1996 after a 63-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Aug 30, 1996
- Review
- 63 days
- Class
- Class II
- Product code
- JHX
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK962549 Vidas Creatine Kinase MB Assay 30-421Biomerieux Vitek, Inc. · 1996
- Descendant · cites it directly · 1 of its ownK120326 AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3…Radiometer Medical Aps · 2012
- Descendant · 2 generations on · 0 of its ownK163462 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K962549 | Vidas Creatine Kinase MB Assay 30-421 | Biomerieux Vitek, Inc. | 1996 | — |
| +1 | K120326 | AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex… | Radiometer Medical Aps | 2012 | — |
| +2 | K163462 | AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX | Radiometer Medical Aps | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | — | Ciba-Corning Magic Lite CK-MB assay Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120326 | AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal… | 2012 | 1 |
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?
- Of its descendants, K120326 (Radiometer Medical Aps, 2012) has gone furthest, with 1 descendant of its own.
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 VIDAS CKMB assay determines the concentration of creatine kinase MB isoenzyme in serum or plasma (heparin or EDTA).
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/K962549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962549: Vidas Creatine Kinase MB Assay 30-421.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962549
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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