ImmuLINK (v3.2)

{0} Traditional 510(k) Premarket Notification werfen ## 510(k) Summary ### Date Prepared May 13, 2024 ### 510(k) Owner Immucor, Inc. 3130 Gateway Drive Norcross, Georgia 30071 Establishment Registration Number: 1034569 ### Contact Information Name of Contact: Steven Appel Phone Number: 770-440-2051 Fax Number: 770-242-8930 ### Modified Device Information | Device Classification Name | Blood Establishment Computer Software and Accessories | | --- | --- | | Tradename | ImmuLINK (v3.2) | | Device Name | Blood Establishment Computer Software and Accessories | | Regulation Number | 864.9165 | | Classification Product Code | MMH | | Classification Advisory Committee | Hematology | | Review Advisory Committee | Hematology | ### Predicate Device Information | Tradename | ImmuLINK (v3.0) | | --- | --- | | Company | Immucor, Inc. | | 510(K) Number | BK230806 | | Decision Date | 04/25/2023 | | Regulation Number | 864.9165 | | Classification Product Code | MMH | ### Device Description ImmuLINK is middleware software that allows the user to link the application software database on automated (and/or semi-automated) blood bank instruments; the user may also link the instrument database(s) with the user's Laboratory Information System (LIS). ImmuLINK is installed on a web server running Microsoft SQL Server 2016 (all editions, including the express). The user accesses the ImmuLINK web application via a PC workstation running either Microsoft Internet Explorer 11, Microsoft Edge, or Chrome as the browser. ImmuLINK (v3.2) Enhanced Antibody ID Tool Features Page 1 of 4 {1} Traditional 510(k) Premarket Notification werfen 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 a software package designed to provide an interface between the operator, blood bank automated (and semi-automated) instruments and Blood Establishment Computer Software, such as the Laboratory Information System (LIS). ImmuLINK allows the 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 Neo, NEO Iris, Galileo Echo and Echo Lumena Blood Bank Systems, and BioArray's Array Imaging System (AIS) semi-automated instrument and associated products. ImmuLINK is used as a remote validation tool so that the result of a test produced by a testing platform can be validated prior to delivery to an LIS. This delivery is characterized by the transmission of an information package. The result validation requires an electronic signature for approval and can be performed remotely without having to be in the laboratory where the result was produced. Results can also be viewed and edited prior to the ImmuLINK validation. ImmuLINK has bi-directional features, whereby test orders can be retrieved from the LIS and then transmitted to the appropriate instrument platform(s). ImmuLINK includes an Antibody ID feature which allows viewing Master List information, executing the Antibody ID algorithm evaluation, assigning an antibody to the result, and printing the results on a master list template. The Antibody ID algorithm for applying rules as defined in AABB manual for rule out/in of antibodies in blood samples. The algorithm provides user with suggested antibody assignments or antibodies that require additional investigation. ## Intended Use ImmuLINK is software intended for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software, and Laboratory Information Systems. ImmuLINK includes the following features and/or functions: - It provides the ability to create and print reports of tests and results. - It supports the ability to compare current results with previous results. - It supports the automatic ordering of reflex tests. - It provides a tool so that test results produced by a testing platform can be remotely validated prior to delivery to an LIS. Results can also be viewed remotely and edited prior to delivery to an LIS. - It provides bi-directional communication between an LIS and instrument platform(s). - It provides a tool to assist with antibody exclusion and identification for Capture-R results that is based upon the approach recommended in the Technical Manual (AABB). ImmuLINK does not provide diagnostic interpretations of antibodies; final clinical interpretation must be performed by a trained user. ImmuLINK (v3.2) Enhanced Antibody ID Tool Features Page 2 of 4 {2} Traditional 510(k) Premarket Notification ## Technological Comparison to Predicate Devices Below is a summary of the technological characteristics of modified device compared to the predicate devices. | Characteristic / Feature | ImmuLINK (v3.0) (Predicate) | ImmuLINK (v3.2) (Modified Device) | | --- | --- | --- | | Classification | II | SAME | | Product Code | MMH | SAME | | Regulation Number | 21 CFR 864.9165 | SAME | | Multi-Instrument Connectivity | Capable of interfacing with more than one instrument at a time | SAME | | Thin-client | A computer or a computer program which depends heavily on some other computer (its server) to fulfill its traditional computation | SAME | | Multiple, Concurrent Users | More than one end user | SAME | | LIS Backup | Continuous results production while your LIS is unavailable | SAME | | Integrated QC | Customer is able to perform the qc using the same run controls and software will check the status of the qc for each instrument | SAME | | Data Storage | Able to store data | SAME | | Data Retrieval | Able to retrieve data | SAME | | Data Mining | Able to turn data into information through analysis | SAME | | Serology Results | Capable of displaying serology-based results | SAME | | Molecular Results | Capable of displaying molecular based results | SAME | | Regulatory Compliance | Documentation control for better regulatory compliance | SAME | | Specimen Routing | Sample processing for better turnaround time | SAME | | User-defined rules | Customer customizable rules based on workflow and lab practices | SAME | | Rules-based decision processing | Yes | SAME | | Real-time delta checking | Current results are checked against previous results (when available) in real time | SAME | | Reflex ordering | Automatic ordering of follow-up test based on previous results | SAME | | Previous results | Allow for storage of prior results | SAME | | Color coding using rules logic | Ability to display information in various colors based on outcome of predefined rules | SAME | | Filtering | Ability to display information based on end user profile | SAME | ImmuLINK (v3.2) Enhanced Antibody ID Tool Features Page 3 of 4 {3} Traditional 510(k) Premarket Notification | Characteristic / Feature | ImmuLINK (v3.0) (Predicate) | ImmuLINK (v3.2) (Modified Device) | | --- | --- | --- | | Reactions Images Storage | Storage of result images | SAME | | Images Review | Provides viewing of result images | SAME | | Instrument Log details | Captures and displays logs from instruments | SAME | | Intended Use | ImmuLINK is software intended for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software, and Laboratory Information Systems. ImmuLINK includes the following features and/or functions: • It provides the ability to create and print reports of tests and results. • It supports the ability to compare current results with previous results. • It supports the automatic ordering of reflex tests. • It provides a tool so that test results produced by a testing platform can be remotely validated prior to delivery to an LIS. Results can also be viewed remotely and edited prior to delivery to an LIS. • It provides bi-directional communication between an LIS and instrument platform(s). • It provides a tool to assist with antibody exclusion for Capture-R results that is based upon the exclusion (rule-out) approach recommended in the Technical Manual (AABB). | ImmuLINK is software intended for use in a blood banking environment as an aid in interfacing and managing data between blood bank instruments, Blood Establishment Computer Software, and Laboratory Information Systems. ImmuLINK includes the following features and/or functions: • It provides the ability to create and print reports of tests and results. • It supports the ability to compare current results with previous results. • It supports the automatic ordering of reflex tests. • It provides a tool so that test results produced by a testing platform can be remotely validated prior to delivery to an LIS. Results can also be viewed remotely and edited prior to delivery to an LIS. • It provides bi-directional communication between an LIS and instrument platform(s). • It provides a tool to assist with antibody exclusion and identification for Capture-R results that is based upon the approach recommended in the Technical Manual (AABB). ImmuLINK does not provide diagnostic interpretations of antibodies; final clinical interpretation must be performed by a trained user. | ### Basis for Claim of Substantial Equivalence The modified ImmuLINK is substantially equivalent to the predicate devices relative to technological characteristics of the software devices. This Traditional 510(k) is submitted to modify legally a marketed, predicate device. Fundamental scientific technology of the proposed device is unchanged from the legally marketed, predicate. There are no significant differences between the modified device and the predicate as related to the Intended Use or Principle of Operation, except for the addition to the Intended Use statement that it provides a tool to assist with antibody exclusion and identification for Capture-R results that is based upon the approach recommended in the Technical Manual (AABB). Based on the indications for use, technological characteristics, and performance testing, that modified ImmuLINK (v3.2) is safe and effective for the intended use described above. ImmuLINK (v3.2) Enhanced Antibody ID Tool Features Page 4 of 4