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K Number
K974000
Device Name
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30
Manufacturer
DIAGNOSTIC CHEMICALS LTD.
Date Cleared
1997-11-04

(14 days)

Product Code
JQB
Regulation Number
862.1360
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the quantitative determination of λ-GT in serum. For IN VITRO diagnostic use.

Device Description

Gamma-Glutamyltransferase-SL Assay

AI/ML Overview

I am sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and details about a study evaluating a device. The document is an FDA letter concerning the 510(k) premarket notification for a "y-Glutamyltransferase-SL Assay." It acknowledges the submission, states the device is substantially equivalent to a predicate device, and outlines regulatory responsibilities. It does not include performance data, study design details, or acceptance criteria for the assay.

§ 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.

(a)
Identification. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.(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.