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K Number
K040920
Device Name
AMYLASE LIQUID REAGENT, MODEL A532-200
Manufacturer
TECO DIAGNOSTICS
Date Cleared
2004-05-10

(32 days)

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

For the quantitative determination of Amylase in human serum and urine. Amylase measurements are used primarily for the diagnostics and treatment of pancreatitis.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "Amylase Liquid Reagent" by TECO Diagnostics. It is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets those criteria, nor any of the other requested details about a study.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text. The letter primarily states that the device is substantially equivalent to a legally marketed predicate device.

§ 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.