← Product Code [MMH](/productcode/MMH) · BK241080

# ImmuLINK (v3.2) (BK241080)

_Immucor, Inc. Norcross, GA · MMH · Aug 6, 2024 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/BK241080

## Device Facts

- **Applicant:** Immucor, Inc. Norcross, GA
- **Product Code:** [MMH](/productcode/MMH.md)
- **Decision Date:** Aug 6, 2024
- **Decision:** SESE
- **Regulation:** 21 CFR 864.9165
- **Device Class:** Class 2
- **Review Panel:** Hematology
- **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 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.

## Device Story

ImmuLINK (v3.2) is middleware software facilitating data integration between blood bank instruments (e.g., Immucor Galileo/Echo systems, BioArray AIS) and Laboratory Information Systems (LIS). It functions as a web-based application on a server, accessed via PC workstations. The device enables remote validation of test results, bi-directional communication for test orders, and data management/reporting. An integrated Antibody ID tool assists users in rule-out/in of antibodies based on AABB Technical Manual guidelines. The software processes instrument data to suggest antibody assignments or identify those requiring further investigation. It does not provide final diagnostic interpretations; clinical decisions remain with the trained laboratory professional. Benefits include improved workflow efficiency, remote result validation, and standardized data management across diverse instrument platforms.

## Clinical Evidence

No clinical data provided. Substantial equivalence is supported by technological comparison and performance testing of the software features.

## Technological Characteristics

Middleware software; web-based architecture (Microsoft SQL Server 2016); thin-client interface via web browsers (IE 11, Edge, Chrome). Features include bi-directional LIS communication, rules-based decision processing, real-time delta checking, and automated reflex ordering. Supports multi-instrument connectivity and concurrent user access. Software utilizes rule-based logic for antibody exclusion/identification based on AABB Technical Manual standards.

## Regulatory 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).

## Predicate Devices

- ImmuLINK (v3.0) ([BK230806](/device/BK230806.md))

## Submission Summary (Full Text)

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>
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## 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

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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

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## 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

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|  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

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**Source:** [https://fda.innolitics.com/device/BK241080](https://fda.innolitics.com/device/BK241080)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com