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K Number
K974053
Device Name
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
Manufacturer
DIAGNOSTIC CHEMICALS LTD.
Date Cleared
1997-12-08

(42 days)

Product Code
JFJ
Regulation Number
862.1070
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
k974037
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the quantitative determination of a-amylase in serum. For IN VITRO diagnostic use.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria, device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document is an FDA 510(k) clearance letter for the "a-Amylase-SL Assay," indicating that the device is substantially equivalent to a predicate device and can be marketed. It states the indications for use and general regulatory information but does not include any performance study details or acceptance criteria.

§ 862.1070 Amylase test system.

(a)
Identification. An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).(b)
Classification. Class II.