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K Number
K980028
Device Name
ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)
Manufacturer
TRACE AMERICA, INC.
Date Cleared
1998-02-02

(28 days)

Product Code
CKA,DEC
Regulation Number
862.1030
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers.

"Alanine amino transferase (ALT/SGPT) measurements are used in the diagnosis and treatment of certain types of liver (e.g. viral hepatitis and cirrhosis) and heart diseases." CFR 862.1030

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "AST (GPT) Liquid Stable 2 Vial Reagent Incorporating DST." It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter is primarily concerned with establishing substantial equivalence to a predicate device and discussing regulatory compliance.

Therefore, I cannot provide the requested information based on the given text. The text does not detail:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, or study type (retrospective/prospective) for a test set.
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication method for a test set.
  5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
  6. Results of a standalone algorithm-only performance study.
  7. The type of ground truth used (e.g., pathology, outcomes data).
  8. The sample size for a training set.
  9. How ground truth for a training set was established.

The letter explicitly states the device's indications for use: "Intended for the In Vitro, quantitative determination of ALT (GPT) activity in human serum on automated chemistry analyzers." It also references the use of Alanine aminotransferase (ALT/SGPT) measurements in the diagnosis and treatment of certain types of liver and heart diseases, as per CFR 862.1030. However, it does not provide performance metrics or study details to support these uses.

§ 862.1030 Alanine amino transferase (ALT/SGPT) test system.

(a)
Identification. An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.