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K Number
K972257
Device Name
N-ASSAY TIA ANTITHROMBIN III TEST KIT
Manufacturer
CRESTAT DIAGNOSTICS, INC.
Date Cleared
1997-10-20

(125 days)

Product Code
DDQ,JBQ
Regulation Number
864.7060
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use for the N-Assay TIA Antithrombin III Test Kit is for the quantification of human antithrombin III in human plasma. AT- III levels less than 60% of normal are associated with increased risk of thromboembolism. The assay of plasma AT-TII is also helpful in monitoring heparin therapy.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the "N-Assay TIA Antithrombin III Test Kit." This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed information about acceptance criteria or specific study results in the format requested.

Therefore, I cannot provide the requested information from the given text.

The document does not contain:

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

The document mainly focuses on the regulatory aspects of the device, its intended use (quantification of human antithrombin III in human plasma, association of low levels with thromboembolism risk, and monitoring heparin therapy), and its classification as substantially equivalent.

§ 864.7060 Antithrombin III assay.

(a)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).(b)
Classification. Class II (performance standards).