LogoFDA 510(k) Search
K Number
K050652
Device Name
SPOTCHEM II CREATININE, AMYLASE & ALP TESTS
Manufacturer
ARKRAY, INC.
Date Cleared
2005-04-06

(23 days)

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

The SPOTCHEM II Creatinine test is intended to measure the concentration of creatinine in serum, plasma, and whole blood. 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.

The SPOTCHEM II Amylase test is intended to measure amylase activity in serum, plasma, and whole blood. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

The SPOTCHEM II ALP test is intended to measure ALP activity in serum, plasma, and whole blood. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) premarket notification approval letter for the Arkray SPOTCHEM II Creatinine, Amylase, and ALP Tests. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill your request for the detailed table and study information based on the provided input. The document is an FDA approval letter, not a study report or clinical trial summary.

To answer your request, you would need a different type of document, such as:

  • A clinical study report
  • A validation study report
  • The 510(k) summary (which might contain a brief overview of performance data but often refers to more detailed reports)
  • The device's Intended Use/Indications for Use statement (which is included in the provided document, but only describes what the device does, not how well it does it or the studies proving efficacy).

§ 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.