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510(k) Data Aggregation
K Number
K012943Device Name
THE QUANTECH FASTRAQ AUTOMATED ANALYZER, AND THE QUANTECH PREPAQ TOTAL HCG TEST CARTRIDGE
Manufacturer
QUANTECH LTD.
Date Cleared
2002-01-18
(140 days)
Product Code
NAL
Regulation Number
862.1155Why did this record match?
Product Code :
NAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The FasTraQ Automated Analyzer in coniunction with the PrePaQ Total hCG Cartridge is intended for use as an aid in the early detection of pregnancy where rapid, quantitative results in the emergency department or where other rapid diagnostics are required. The assay is to be used with patient whole blood samples.
The Quantech PrePaQ Total hCG Test Cartridge is intended for use with the FasTraQ Automated Analyzer to provide rapid, quantitative measurement of human chorionic gonadotropin (hCG) in whole blood for the determination of pregnancy. The Analyzer and hCG Cartridge combine ease of use and rapid turnaround time with laboratory-quality performance and reliability. The FasTraQ System is designed for use by non-laboratory medical professionals in emergency departments, STAT or central laboratories.
Device Description
The PrePaQ Cartridge in coniunction with the FasTraQ Automated Analyer is use to quantitate hCG in whole blood using surface plasmon resonance (SPR). The Quantech PrePaQ Total ß-hCG assay is based on the principle of two site, or sandwich immunoassay in combination with SPR surface mass measurement. Each PrePaQ cartridge contains a solid phase ß-hCG monoclonal antibody immobilized onto a gold surface. An anti-alpha hCG polyclonal antibody conjugated to alkaline phosphatase is attached to the antigen to form the sandwich. An enhancing solution is used to further increase the mass on the surface.
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K Number
K990258Device Name
QUANTECH TOTAL B-HCG ASSAY
Manufacturer
QUANTECH LTD.
Date Cleared
1999-12-21
(328 days)
Product Code
NAL
Regulation Number
862.1155Why did this record match?
Product Code :
NAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Quantech Total β-hCG Assay is intended to be used, as aid in the early detection of pregnancy.
The Quantech Total β-hCG Assay is intended to be used for the quantitative determination of human chorionic gonadotropin in EDTA-stabilized plasma, for the early detection of pregnancy.
Device Description
The Quantech Total ß-hCG assay is based on the principle of two site, or sandwich immunoassay in combination with surface plasmon resonance (SPR) surface mass measurement. Each test module contains a solid phase anti-ß-hCG monoclonal antibody immobilized onto a gold surface. An anti-hCG polyclonal antibody, used to enhance the specific detection by SPR is introduced sequentially.
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