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K Number
K974909
Device Name
SYNERMED CREATININE REAGENT KIT
Manufacturer
SYNERMED INTL., INC.
Date Cleared
1998-02-24

(55 days)

Product Code
CGX
Regulation Number
862.1225
Type
Traditional
Panel
Clinical Chemistry
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Synermed® Creatinine reagent is intended for use in the quantitative determination of creatinine in serum by manual and automated methods.

Device Description

Creatinine Reagent kit

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter for a Creatinine Reagent kit, indicating that the device is substantially equivalent to a predicate device. It defines the "Indications For Use" but does not detail acceptance criteria, study methods, sample sizes, or expert qualifications beyond stating the intended use of the reagent.

Therefore, I cannot generate the requested table and paragraphs based on the input.

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.