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K Number
K991109
Device Name
CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
Manufacturer
A.P. TOTAL CARE, INC.
Date Cleared
1999-05-25

(54 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 creatinine reagents: Alkaline Diluent(R1), product No. CA105-01 and Piccio Acid ed the second of a CA105-02-are intended for Invitro Diagnostic use in the automated, The creatinine reagents: Alkaline Diluent(R1), product No. CH10507 use in the automated, (R2), product No. CA105-02 are intended for Invitro Diagnosic use in the automated, (R2), product No. CA105-02 are intended for Interest of the

Device Description

CREATININE Reagent

AI/ML Overview

The provided document is a 510(k) clearance letter for a medical device called "CREATININE Reagent". It outlines the FDA's decision to clear the device for marketing based on substantial equivalence to a predicate device. However, the document does not contain any information regarding the acceptance criteria, study details, performance data, or ground truth establishment for the CREATININE Reagent device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a regulatory approval letter, not a scientific study report.

§ 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.