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510(k) Data Aggregation
K Number
K140691Device Name
IG_PLEX CELIAC DGP PANEL
Manufacturer
SQI DIAGNOSTICS SYSTEMS INC.
Date Cleared
2014-11-06
(232 days)
Product Code
MVM, MST, NSU
Regulation Number
866.5660Why did this record match?
Applicant Name (Manufacturer) :
SQI DIAGNOSTICS SYSTEMS INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ig plex Celiac DGP Panel is an in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (TG) in human serum. The test is intended for use in clinical laboratories as an aid in the disease in conjunction with other laboratory and clinical findings, and requires the sqid-X system.
Device Description
The Ig plex Celiac DGP Panel is a consumable reagent kit. It is designed to run on the sqid-X system. The kit includes a microarray plate, reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM.
The assay detects the presences of the IgA and IgG classes of antibody, and the IgA and lgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the sqid-X system that reports all analytes simultaneously to aid in the diagnosis of celiac disease.
The system is a multiplex immunoassay analyzer that semi-automates the protocol of a specific lg plex assay from plate washing to reporting of all assay markers for each individual patient sample. The system combines manual liquid handling (samples and reagents) with automated steps for washing, scanning, data analyses and reporting. Results for each patient sample are obtained simultaneously for each of the four markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
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