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510(k) Data Aggregation
K Number
K180627Device Name
Macroduct Advanced Model 3710
Manufacturer
ELITechGroup Inc.
Date Cleared
2018-07-27
(140 days)
Product Code
KTB
Regulation Number
890.5525Why did this record match?
Applicant Name (Manufacturer) :
ELITechGroup Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation of sweat from humans for analysis for the diagnosis of cystic fibrosis.
Device Description
The Macroduct Advanced Model 3710 Sweat Collection System is intended only for clinical laboratory use by qualified medical personnel for stimulation and collection of sweat from humans for analysis for the diagnosis of cystic fibrosis.
The Macroduct Advanced Sweat Collection System consists of the Macroduct Advanced Model 3710, which is a microprocessor-controlled device powered from a rechargeable lithium-ion battery, battery charging power supply and cord for charging the battery, electrode cable assembly, and a kit of single-use supplies (Pilogel discs, collectors, and straps). The system safely and efficiently accomplishes the stimulation of human sweat through pilocarpine iontophoresis using the Macroduct Advanced Model 3710. The Macroduct Advanced Sweat Collector collects a sample of the stimulated sweat. Markings on the collection tube of the collector indicate if a sufficient sweat rate is achieved during the collection of sweat. The sample can then be analyzed for indications of cystic fibrosis with the Sweat-Chek™ Sweat Conductivity Analyzer using the principle of total electrolyte concentration in the sweat sample; or with the ChloroChek® Chloridometer® using the principle of coulometric titration.
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