510(k) · Cleared
ClearedModification to Cardiac Status CK-MB/Myoglobin Rapid One-Step Test, Lifesign MI CK-MB/Myoglobin, Lifesign CK-MB/Myoglobi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Princeton BioMeditech Corp. · JHT Chromatographic Separation, Cpk Isoenzymes
Cleared on May 28, 1999 after a 52-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- May 28, 1999
- Review
- 52 days
- Class
- Class II
- Product code
- JHT
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JHT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 JHT devicesJHT Chromatographic Separation, Cpk Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHT
FDA has decided no JHT device since 2007.
Median 510(k) review, days · JHT
Too few JHT 510(k)s in any year since 2007 to give a median.
Recalls per year · JHT
No recall names JHT since 2007.
Adverse event reports per year · JHT
No MAUDE report names JHT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991299: Modification to Cardiac Status CK-MB/Myoglobin Rapid One-Step Test, Lifesign MI CK-MB/Myoglobin, Lifesign CK-MB/Myoglobi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991299
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026