BK251256 · Immucor, Inc. Norcross, Georgia 30071 · MMH · Oct 24, 2025 · Hematology
Device Facts
Record ID
BK251256
Device Name
ImmuLINK (v3.3)
Applicant
Immucor, Inc. Norcross, Georgia 30071
Product Code
MMH · Hematology
Decision Date
Oct 24, 2025
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for 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 that is based upon the approach recommended in the Technical Manual (AABB). ImmuLINK does not provide diagnostic interpretations of antibodies; final interpretation of results must be performed by a trained user.
Device Story
ImmuLINK is middleware software facilitating data integration between blood bank instruments (e.g., Immucor Galileo/Echo systems, BioArray AIS) and Laboratory Information Systems (LIS). It collects sample, donor, and patient data; provides tools for customizable reporting, reflex test ordering, and remote result validation. Operators (laboratory staff) access the web-based interface via PC workstations to review, edit, and electronically sign results before LIS transmission. The system includes an Antibody ID tool assisting in exclusion/identification based on AABB Technical Manual guidelines; it does not provide diagnostic interpretations. Bi-directional communication allows LIS test orders to be sent to instruments. Benefits include improved workflow efficiency, remote validation capabilities, and centralized data management.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on technological characteristics and performance testing of software functionality.
Technological Characteristics
Middleware software; web-based architecture; Windows Server 2022 or Windows 11 Professional; Microsoft SQL Server 2019/2022; thin-client deployment; bi-directional LIS/instrument connectivity; rules-based decision processing; supports serology and molecular result display; electronic signature capability.
Indications for Use
Indicated for use in blood banking environments to interface and manage data between blood bank instruments, Blood Establishment Computer Software, and Laboratory Information Systems. Intended for use by trained laboratory personnel for data integration, remote result validation, and antibody exclusion/identification assistance.
Regulatory Classification
Identification
Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. This generic type of device may include a BECS accessory, a device intended for use with BECS to augment the performance of the BECS or to expand or modify its indications for use.
Special Controls
*Classification.* Class II (special controls). The special controls for these devices are:(1) Software performance and functional requirements including detailed design specifications (
*e.g.,* algorithms or control characteristics, alarms, device limitations, and safety requirements).(2) Verification and validation testing and hazard analysis must be performed.
(3) Labeling must include:
(i) Software limitations;
(ii) Unresolved anomalies, annotated with an explanation of the impact on safety or effectiveness;
(iii) Revision history; and
(iv) Hardware and peripheral specifications.
(4) Traceability matrix must be performed.
(5) Performance testing to ensure the safety and effectiveness of the system must be performed, including when adding new functional requirements (
*e.g.,* electrical safety, electromagnetic compatibility, or wireless coexistence).
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## 510(k) Summary
### Date Prepared
July 30, 2025
### 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 (v3.3) |
| 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 (v3.2) |
| --- | --- |
| Company | Immucor, Inc. |
| 510(K) Number | BK241080 |
| Decision Date | 08/06/2024 |
| 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 Windows Server 2022 64-bit (Standard edition) with Microsoft SQL Server 2019 or 2022 (all editions, including the express). For customers not able to utilize server installation, ImmuLINK can be installed on a PC workstation running
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Windows 11 Professional and Microsoft SQL Server 2022 Express. The user accesses the ImmuLINK web application via a PC workstation running either Microsoft Edge or Google Chrome as the browser.
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|manage includes an Antibody ID feature which provides review of Master List for Capture-R products combined with instrument results and to facilitate optional antibody exclusion and identification capabilities. The Antibody ID feature can optionally include results from manual testing using liquid reagent red blood cells. ImmuLINK does not provide diagnostic interpretations of antibodies; final interpretation of results must be performed by a trained user.
ImmuLINK includes an archive feature which is used to create and view result archives, which are stored in a secure environment.
## 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).
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- It provides a tool to assist with antibody exclusion and identification that is based upon the approach recommended in the Technical Manual (AABB). ImmuLINK does not provide diagnostic interpretations of antibodies; final interpretation of results must be performed by a trained user.
### Technological Comparison to Predicate Devices
Below is a summary of the technological characteristics of modified device compared to the predicate devices.
| Characteristic / Feature | ImmuLINK (v3.2) (Predicate) | ImmuLINK (v3.3) (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 |
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| Characteristic / Feature | ImmuLINK (v3.2) (Predicate) | ImmuLINK (v3.3) (Modified Device) |
| --- | --- | --- |
| 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 |
| 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 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 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 that is based upon the approach recommended in the *Technical Manual* (AABB). ImmuLINK does not provide diagnostic interpretations of antibodies; final interpretation of results 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, or safety.
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Based on the indications for use, technological characteristics, and performance testing, that modified ImmuLINK (v3.3) is safe and effective for the intended use described above.
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