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K Number
K093939
Device Name
ADVIA CHEMISTRY SALICYLATE REAGENT
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS
Date Cleared
2010-05-19

(148 days)

Product Code
DKJ
Regulation Number
862.3830
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For in vitro diagnostic use in the quantitative determination of salicylate in human serum and plasma (lithium heparin) on the ADVIA 1650 Chemistry systems. Such measurements are used in the diagnosis of salicylate toxicity and overdose

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. The document is an FDA 510(k) clearance letter for the "ADVIA Chemistry Salicylate Reagent" and primarily discusses regulatory compliance and indications for use. No clinical study data or performance metrics are present in the provided pages.

§ 862.3830 Salicylate test system.

(a)
Identification. A salicylate test system is a device intended to measure salicylates, a class of analgesic, antipyretic and anti-inflammatory drugs that includes aspirin, in human specimens. Measurements obtained by this device are used in diagnosis and treatment of salicylate overdose and in monitoring salicylate levels to ensure appropriate therapy.(b)
Classification. Class II.