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K Number
K123802
Device Name
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
Manufacturer
MEDICA CORP.
Date Cleared
2013-03-01

(81 days)

Product Code
CIG
Regulation Number
862.1110
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The EasyRA TBIL reagent is intended for the quantitative measurement of Total Bilirubin in human serum and plasma of adults on the Medica EasyRA analyzer in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use only.

The EasyRA DBIL reagent is intended for the quantitative measurement of Direct Bilirubin in human serum and plasma of adults on the Medica EasyRA analyzer in clinical laboratories. Bilirubin measurements are used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder block. For in vitro diagnostic use only.

The EasyRA CK reagent is intended for the quantitative determination of Creatine Kinase (CK) in human serum and plasma, using the MEDICA "EasyRA Chemistry analyzer" in clinical laboratories. Measurements of CK are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy. For in vitro diagnostic use only.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for in-vitro diagnostic reagents, not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and ground truth for an AI/ML device is not applicable here.

The document discusses the substantial equivalence of the EasyRA Total Bilirubin Reagent, EasyRA Direct Bilirubin Reagent, and EasyRA Creatinine Kinase Reagent to legally marketed predicate devices. The review is focused on the regulatory classification and general controls provisions for these diagnostic reagents.

§ 862.1110 Bilirubin (total or direct) test system.

(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.