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510(k) Data Aggregation
K Number
K111356Device Name
ASIMANAGER - AT
Manufacturer
ARLINGTON SCIENTIFIC, INC.
Date Cleared
2011-11-09
(177 days)
Product Code
JQT
Regulation Number
862.2400Why did this record match?
Product Code :
JQT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ASiManager-AT is intended to be used as an integrated digital particle analyzer to objectively interpret the ASI RPR Card Test for Syphilis. The ASiManager-AT is designed to provide standardized test interpretation, an initial predictive titer analysis, and provides for storage, retrieval, and transmittal of the test results. It is intended to be acquired, possessed and used only by health care professionals. For in vitro Diagnostic Use Only, not intended for screening blood and tissue donors.
Device Description
The ASiManager-AT is an integrated digital particle analyzer designed to objectively interpret certain slide agglutination tests manufactured by Arlington Scientific Inc. (ASI). Qualitative and semiquantitative tests are performed by laboratory professionals who use the ASiManager-AT to provide standardized test interpretation using criteria that define reactive and nonreactive agglutination reactions. The ASiManager-AT also delivers an initial predictive titer analysis for the ASI RPR Card Test for Syphilis.
The ASiManager-AT employs a CCD (charge-coupled device) camera that uses light reflectance to create a highly sensitive and high-resolution image of the agglutination immunoassay. This image is then analyzed by the proprietary software algorithm to interpret the agglutination pattern.
The ASiManager-AT further provides tools that enable the creation, storage. retrieval and transmittal of the test results.
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