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6.0 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR§807.92.
6.1 Applicant Information
|Date Prepared:||June 13, 2012|
|Address:||3130 Gateway Drive
Norcross, Georgia 30071
|Establishment Registration Number:||1034569|
|Contact Person:||Steven Appel
Regulatory Affairs Manager
6.2 Device Information
|Product Name:||Software, Blood Bank, Stand Alone|
6.3 Predicate Device
Instrument Manager v8.10, BK100046 (Cleared August 12, 2010)
6.4 Device Description
ImmuLINK is software designed to provide an interface between the user, blood bank instruments, and Blood Establishment Computer. ImmuLINK allows integration of sample, donor, or patient data that has been collected from multiple sources and provides data management tools to create customizable reports from the diverse data.
ImmuLINK is configurable to interface with multiple instrument platforms including (but not limited to) Immucor's Galileo, Galileo Neo and Galileo Echo Blood Bank Systems.
6.5 Intended Use
ImmuLINK is software for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments and Blood Establishment Computer Software.
ImmuLINK is substantially equivalent to another currently marketed predicate, Data Innovations’ Instrument Manager.
Review of the intended use, technical characteristics, and the results of internal validation (alpha testing), external beta testing, and user acceptance testing demonstrates that ImmuLINK is safe, effective, meets its specifications, and functions as expected within its intended use.