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K Number
K981012
Device Name
AIA-PACK MYOGLOBIN ASSAY
Manufacturer
TOSOH MEDICS, INC.
Date Cleared
1998-05-28

(71 days)

Product Code
DDR
Regulation Number
866.5680
Type
Traditional
Panel
IM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AIA-PACK Myoglobin is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of myoglobin in human serum and plasma on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis and monitoring of cardiac disease.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the AIA-PACK Myoglobin Assay manufactured by Tosoh Medics, Inc. It grants clearance for the device, stating it is substantially equivalent to legally marketed predicate devices.

However, this document does NOT contain the following information that you requested:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes used for test sets or their data provenance.
  • Number and qualifications of experts for ground truth.
  • Adjudication methods.
  • Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
  • Details on standalone algorithm performance.
  • Type of ground truth used.
  • Sample size for and establishment of ground truth for training sets.

The letter explicitly states the intended use of the device: "AIA-PACK Myoglobin is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of myoglobin in human serum and plasma on specific TOSOH AIA System analyzers. Measurements obtained by this device aid in the diagnosis and monitoring of cardiac disease."

To obtain the information you are seeking, you would need to consult the original 510(k) submission (K981012) from Tosoh Medics, Inc. to the FDA, which would detail the studies and data used to demonstrate substantial equivalence. This clearance letter is merely the FDA's approval of that submission.

§ 866.5680 Myoglobin immunological test system.

(a)
Identification. A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.(b)
Classification. Class II (performance standards).