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K Number
K980030
Device Name
AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Manufacturer
TRACE AMERICA, INC.
Date Cleared
1998-01-30

(25 days)

Product Code
CIT
Regulation Number
862.1100
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Intended for the the In Vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers. "Aspartate amino transferase (AST/SGOT) measurements are used in the diagnosis and treatment of certain types of liver and heart disease.... " CFR 862.1100

Device Description

AST (GOT) LIQUID STABLE 2 VIAL - (DST) REAGENT

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device (AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST). It is a regulatory approval document and does not contain the information requested in your prompt regarding acceptance criteria, study details, or AI performance metrics.

Therefore, I cannot extract the following information from the provided text:

  1. A table of acceptance criteria and the reported device performance: This document does not describe performance metrics or acceptance criteria for the device itself beyond its intended use.
  2. Sample sizes used for the test set and the data provenance: No study details are provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No study details are provided.
  4. Adjudication method for the test set: No study details are provided.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a diagnostic reagent, not an AI system or imaging device requiring human reader interpretation in the context of an MRMC study.
  6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
  7. The type of ground truth used: No study details are provided.
  8. The sample size for the training set: Not applicable, as this is not an AI algorithm.
  9. How the ground truth for the training set was established: Not applicable, as this is not an AI algorithm.

What the document does state about the device:

  • Device Name: AST (GOT) Liquid Stable 2 Vial Reagent Incorporating DST
  • Indications for Use: Intended for the in vitro, quantitative determination of AST (GOT) activity in human serum on automated chemistry analyzers.
  • Purpose of AST (GOT) measurements (from CFR 862.1100): Used in the diagnosis and treatment of certain types of liver and heart disease.
  • Regulatory Classification: Class II
  • Determination: Substantially equivalent to devices marketed prior to May 28, 1976.

To answer your prompt, you would need a clinical study report or a 510(k) summary document that typically accompanies this clearance letter, which would describe the performance characteristics and testing conducted for the device.

§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.

(a)
Identification. An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.