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K Number
K984359
Device Name
AIA-PACK TROPONIN I ASSAY
Manufacturer
TOSOH MEDICS, INC.
Date Cleared
1998-12-23

(16 days)

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

AIA-PACK Troponin I is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of cardiac troponin I (cTnl) in human serum and plasma on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis of acute myocardial infarction (AMI).

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter for the AIA-Pack® Troponin I Assay, dated December 23, 1998. It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is thus cleared for marketing.

However, this document does not contain the detailed information needed to answer the questions about acceptance criteria and study design. It is a regulatory clearance document, not a scientific study report.

Specifically, the document does not include:

  • A table of acceptance criteria or reported device performance metrics like sensitivity, specificity, accuracy, etc.
  • Information on sample sizes for test sets (or training sets).
  • Details about data provenance (e.g., country of origin, retrospective/prospective).
  • The number or qualifications of experts used to establish ground truth.
  • Adjudication methods.
  • Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  • Details about standalone (algorithm-only) performance.
  • The type of ground truth used (e.g., pathology, outcomes data).
  • How ground truth for any training set was established.

To obtain this information, one would typically need to consult the full 510(k) submission, study reports, or peer-reviewed publications related to the AIA-Pack® Troponin I Assay. The provided document is merely the FDA's regulatory decision letter.

§ 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.