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Ast Or Sgot

FDA 510(k)

Class II (US FDA 510(k))

510(k) K971344

by Carolina Liquid Chemistries Corp.

Identifiers

510(k) Number
K971344 FDA 510(k)
FDA Product Code
CIT FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1100 FDA 510(k)
Regulation Number
862.1100 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a NADH Oxidation/NAD Reduction reagent used for measuring aspartate aminotransferase (AST) and serum glutamate oxaloacetate transaminase (SGOT) levels in clinical chemistry. AST and SGOT are enzymes that indicate liver function and tissue damage, and their quantification aids in diagnosing conditions such as hepatitis, cirrhosis, and myocardial infarction.

The AST or SGOT Reagent is supplied as a liquid reagent for use in clinical chemistry analyzers. It is intended for single-use in vitro diagnostic testing and requires no sterilization beyond standard laboratory protocols. The device is classified as Class II under FDA regulations (21 CFR 862.1100) and was cleared via a Traditional 510(k) pathway in 1997 (K971344). Storage conditions and expiration dates are specified on the reagent label and must be adhered to for accurate results.

Frequently asked questions

What is the AST or SGOT Reagent used for in clinical settings?

The AST or SGOT Reagent is designed for measuring aspartate aminotransferase (AST) and serum glutamate oxaloacetate transaminase (SGOT) levels in clinical chemistry analyzers. These enzymes are critical biomarkers for assessing liver function and detecting tissue damage, helping diagnose conditions such as hepatitis, cirrhosis, and myocardial infarction. By quantifying AST and SGOT, clinicians can evaluate liver health and identify potential underlying pathologies.

How is the AST or SGOT Reagent supplied and intended for use?

The reagent is supplied as a liquid formulation specifically for use in clinical chemistry analyzers. It is intended exclusively for single-use in vitro diagnostic testing. No additional sterilization beyond standard laboratory protocols is required, as the reagent is prepared for direct use in clinical settings. This ensures consistency and reliability in diagnostic results without the need for further processing.

Is the AST or SGOT Reagent sterile, and what are its storage requirements?

The AST or SGOT Reagent does not require sterilization beyond standard laboratory protocols, as it is designed for single-use and intended to be used directly in clinical chemistry analyzers. Storage conditions and expiration dates are clearly labeled on the reagent packaging, and these must be strictly followed to maintain the accuracy and integrity of the test results. Adhering to these guidelines ensures optimal performance and reliability of the reagent.

What regulatory pathway was followed for the clearance of this reagent?

The AST or SGOT Reagent was cleared through the FDA’s Traditional 510(k) pathway, specifically under the classification of Class II devices (21 CFR 862.1100). This pathway demonstrates that the device is substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards. The clearance number for this device is K971344, granted in 1997.

Are there different models or sizes available for the AST or SGOT Reagent?

The AST or SGOT Reagent is supplied as a single liquid formulation without varying models or sizes. It is standardized for use in clinical chemistry analyzers and is intended to be consistent across diagnostic applications. The reagent’s specifications and performance are designed to meet the needs of standard laboratory testing protocols for AST and SGOT measurement.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: AST OR SGOT (K971344) — FDA 510(k) | Innolitics, Carolina Liquid Chemistries, Carolina Liquid Chemistries Corp. FDA Filings - FDA.report, Carolina Liquid Chemistries Corp. · DeviceClearance, CAROLINA LIQUID CHEMISTRIES CORPORATION AU-241 CAROLINA LIQUID ... - RevMed

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Carolina Liquid Chemistries Corp.

Sources (1)

  • FDA 510(k) K971344 24 fields · synced Oct 1, 2026