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K Number
K014024
Device Name
MODIFICATION TO ALPHA DX SYSTEM
Manufacturer
FIRST MEDICAL, INC.
Date Cleared
2001-12-18

(12 days)

Product Code
MMI,GKF,JHX,KHO
Regulation Number
862.1215
Type
Special
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Alpha Dx Cardiac Panel Test Kit is intended for use with the Alpha DX Analyzer. The Alpha DX Cardiac Panel Test Kits are fluorescence Immunoassay Analyzer for the rapid measurement of myoglobin, CK, CK-MB, and Tnl.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot provide a comprehensive description of the acceptance criteria and the study that proves the device meets them. The document is a 510(k) clearance letter from the FDA for the "Alpha DX System," and it primarily concerns the regulatory approval process rather than detailed performance data or study results.

The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. It mentions the "Alpha Dx Cardiac Panel Test Kit" for the rapid measurement of myoglobin, CK, CK-MB, and Tnl with the Alpha DX Analyzer, but it does not include the following crucial information for your request:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for test sets.
  • Data provenance (country of origin, retrospective/prospective).
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
  • Results of a standalone algorithm-only performance study.
  • Type of ground truth used (e.g., pathology, outcomes).
  • Sample size for the training set.
  • How ground truth for the training set was established.

To obtain this information, you would typically need to consult the original 510(k) submission document itself, which would contain the detailed study protocols, results, and justification for the substantial equivalence claim. The provided FDA letter is merely the official notification of market clearance.

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.