510(k) · Cleared
ClearedAlpha DX Analyzer 01-0100, Alpha DX Myo/CK/CK-MB/Tni Cardiac Panel Test Kit 03-0001, Alpha DX CK/CK-MB Panel Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
First Medical, Inc. · MMI Immunoassay Method, Troponin Subunit
Cleared on Feb 4, 1998 after a 42-day review. The FDA summary names its predicate without a number.
- Decided
- Feb 4, 1998
- Review
- 42 days
- Class
- Class II
- Product code
- MMI
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a 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 MMI? 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 MMI device
- #1 K253051 i-STAT hs-TnI cartridge with the i-STAT…score 13.0 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
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 |
|---|---|---|---|
| * | — | Dade Stratus Myoglobin Fluorometric Enzyme Immunoassay Named without a submission number | |
| * | — | Johnson & Johnson Vitros CK Slide Named without a submission number | |
| * | — | Dade Stratus CK-MB Fluorometric Enzyme Immunoassay Named without a submission number | |
| * | — | Dade Stratus Cardiac Troponin I Fluorometric Enzyme Immunoassay Named without a submission number | |
| * | — | Beckman Access Troponin I Immunoassay System Named without a submission number | |
| * | — | Dade Stratus II Fluorometric Immunoassay System Named without a submission 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 MMI devicesMMI Immunoassay Method, Troponin Subunit: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MMI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMI
266in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MMI
805in 2025
MAUDE reports naming product code MMI, 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 | 3 | 190 | 6 | 352 |
| 2008 | 1 | — | 2 | 837 |
| 2009 | 1 | — | 3 | 1,010 |
| 2010 | 2 | — | 5 | 1,335 |
| 2011 | 1 | — | 1 | 2,406 |
| 2012 | 0 | — | 6 | 1,841 |
| 2013 | 2 | — | 0 | 1,394 |
| 2014 | 0 | — | 1 | 1,150 |
| 2015 | 0 | — | 1 | 831 |
| 2016 | 0 | — | 0 | 487 |
| 2017 | 1 | — | 0 | 618 |
| 2018 | 4 | 344 | 0 | 487 |
| 2019 | 3 | 88 | 1 | 521 |
| 2020 | 0 | — | 1 | 387 |
| 2021 | 1 | — | 1 | 356 |
| 2022 | 1 | — | 0 | 507 |
| 2023 | 3 | 270 | 0 | 748 |
| 2024 | 2 | — | 1 | 921 |
| 2025 | 4 | 266 | 0 | 805 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer to provide rapid, quantitative and simultaneous measurement of myoglobin, creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB) and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI). The Analyzer and Cardiac Panel Test Kit combine ease of use and rapid turnaround time with laboratory-quality performance and…
Read the full statement (109 words)
The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha Dx Analyzer to provide rapid, quantitative and simultaneous measurement of myoglobin, creatine kinase (CK), creatine kinase MB isoenzyme (CK-MB) and cardiac troponin I (TnI) in whole blood or serum to aid in the diagnosis of acute myocardial infarction (AMI). The Analyzer and Cardiac Panel Test Kit combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. With factory calibration, built-in bilevel quality controls and closed tube sampling, the system can be used in the central laboratory, STAT lab, emergency department, coronary care unit, chest pain center and other point of care locations.
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/K974839 · printed Nov 5, 2026
Cite this page
510(k) Report. “K974839: Alpha DX Analyzer 01-0100, Alpha DX Myo/CK/CK-MB/Tni Cardiac Panel Test Kit 03-0001, Alpha DX CK/CK-MB Panel Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K974839
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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