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K Number
K973292
Device Name
I-STAT SYSTEM
Manufacturer
I-STAT CORP.
Date Cleared
1997-10-20

(48 days)

Product Code
CGL,CCL
Regulation Number
862.1225
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the quantitative determination of Creatinine (Crea) in whole blood with the i-STAT analyzer. 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.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets said criteria. The document is an FDA 510(k) clearance letter for the i-STAT Creatinine Test, indicating its substantial equivalence to a legally marketed predicate device. It briefly mentions the intended use of the device: "For the quantitative determination of Creatinine (Crea) in whole blood with the i-STAT analyzer. 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." However, it does not provide any specific performance metrics, study details, or acceptance criteria.

§ 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.