# 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

- Pathway: 510(k) (Traditional)
- Applicant: First Medical, Inc.
- Decided: Feb 4, 1998 after 42 days
- Product code: MMI (Immunoassay Method, Troponin Subunit)
- Device class: 2
- Regulation: 21 CFR 862.1215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dade Stratus Myoglobin Fluorometric Enzyme Immunoassay: named in the summary without a submission number
- (no number) Johnson & Johnson Vitros CK Slide: named in the summary without a submission number
- (no number) Dade Stratus CK-MB Fluorometric Enzyme Immunoassay: named in the summary without a submission number
- (no number) Dade Stratus Cardiac Troponin I Fluorometric Enzyme Immunoassay: named in the summary without a submission number
- (no number) Beckman Access Troponin I Immunoassay System: named in the summary without a submission number
- (no number) Dade Stratus II Fluorometric Immunoassay System: named in the summary without a submission number

## Indications for use
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.

Source page: https://510kreport.com/device/K974839
Methodology: https://510kreport.com/methodology