BK230806 · Immucor, Inc. Norcross, GA · MMH · Apr 25, 2023 · Hematology
Device Facts
Record ID
BK230806
Device Name
ImmuLINK (v3.0)
Applicant
Immucor, Inc. Norcross, GA
Product Code
MMH · Hematology
Decision Date
Apr 25, 2023
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 for Capture-R results that is based upon the exclusion (rule-out) approach recommended in the Technical Manual (AABB).
Device Story
ImmuLINK (v3.0) is a blood bank software interface; connects automated/semi-automated instruments (e.g., Galileo Neo, NEO Iris, Echo, AIS) with LIS and Blood Establishment Computer Software. Inputs: patient/donor sample data, test results from instruments. Processing: data integration, remote validation, bi-directional communication, and new Antibody ID feature. Output: validated test results, customizable reports, antibody exclusion suggestions. Used in blood banks/reference labs by laboratory personnel. Antibody ID feature uses AABB Technical Manual-based rules to suggest antibody assignments or identify need for further investigation; excludes antibodies using antigen-positive cells. Benefits: streamlined workflow, remote result validation, standardized antibody rule-out process, improved regulatory compliance.
Clinical Evidence
No clinical data provided. Substantial equivalence is supported by technological comparison and performance testing of the software's rule-based algorithm against established AABB Technical Manual guidelines.
Technological Characteristics
Software-based data management system; thin-client architecture; supports multi-instrument connectivity and concurrent users. Features include real-time delta checking, reflex ordering, and rules-based decision processing. Algorithm is rule-based, derived from AABB Technical Manual (18th Ed) for antibody exclusion. Connectivity: bi-directional LIS/instrument interface. Data storage and retrieval capabilities included.
Indications for Use
Indicated for use by trained laboratory personnel in a blood banking environment to interface and manage data between blood bank instruments, Blood Establishment Computer Software, and Laboratory Information Systems, including antibody exclusion (rule-out) for Capture-R results.
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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Traditional 510(k) Premarket Notification
IMMUCOR
## 7.0 510(k) Summary
### Date Prepared
April 14, 2023
### 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 (v3.0) |
| 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, V.1.7 |
| --- | --- |
| Company | Immucor, Inc. |
| 510(K) Number | BK150333 |
| Decision Date | 11/19/2015 |
| Regulation Number | 864.9165 |
| Classification Product Code | MMH |
| Tradename | Bio-Rad IH-AbID Integrated Antibody Identification |
| --- | --- |
| Company | Bio-Rad Medical Diagnostics GmbH Industriestrasse 1 |
| 510(K) Number | BK220769 |
| Decision Date | 12/7/2022 |
| Regulation Number | 864.9165 |
| Classification Product Code | MMH |
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## Device Description
ImmuLINK (ImmuLINK®|manage combined with ImmuLINK®|archive) 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|manage, combined with ImmuLINK|archive, 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|manage, combined with ImmuLINK|archive, 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|manage 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|manage validation.
ImmuLINK|manage 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 optional antibody exclusion (rule-out) capabilities.
ImmuLINK|archive is used to create and view result archives, which are stored in a secure environment.
### Relationship between Instruments and ImmuLINK|manage
The diagram below summarizes the functional relationships between instruments and ImmuLINK|manage, using the example of two (2) blood bank instruments:
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# ImmuLINK Antibody ID Feature
Antibody ID (also referred to as Panel ID) 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 will provide user with suggested antibody assignments or antibodies that require additional investigation.
The algorithm available with Antibody ID is a first step in the antibody identification process. The algorithm will exclude using one double dose example of an antigen where the genetic background is known. The algorithm rules were derived using the AABB Technical Manual, 18th Edition, Chapter 16 – “Identification of Antibodies to Red Cell Antigens”.
In cases like Lewis and P1 blood groups, the antigenic presentation cannot be determined. To accommodate this the algorithm will use either two or three antigen positive cells that do not react with the sample to exclude. Immucor personnel can configure ImmuLINK to use two or three cells according to customer policy or practice. In the presence of anti-D, C and E can be excluded on single dose cells (r'r, and r"r). This exclusion is included in the algorithm calculation of ImmuLINK.
# 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
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Addition of Antibody ID Feature
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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).
### Technological Comparison to Predicate Devices
Below is a summary of the technological characteristics of modified device compared to the predicate devices.
| Characteristic / Feature | Predicate Device: ImmuLINK (v.1.7) | Modified Device: ImmuLINK (v3.0) |
| --- | --- | --- |
| 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 |
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| Characteristic / Feature | Predicate Device: ImmuLINK (v.1.7) | Modified Device: ImmuLINK (v3.0) |
| --- | --- | --- |
| 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 |
| 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). | 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). |
| Characteristic / Feature | Bio-Rad IH-AbID Integrated Antibody Identification | Modified Device: ImmuLINK (v3.0) |
| --- | --- | --- |
| Classification | II | SAME |
| Product Code | MMH | SAME |
| Regulation Number | 21 CFR 864.9165 | SAME |
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| Characteristic / Feature | Bio-Rad IH-AbID Integrated Antibody Identification | Modified Device: ImmuLINK (v3.0) |
| --- | --- | --- |
| Tests managed | Antibody Screening Antibody Identification | SAME |
| User interface | Duplicates the existing antibody test procedures used in blood reference laboratories in a graphical electronic form. | SAME |
| Use environment | Blood bank software used by reference laboratories and transfusion services—an application with functionality specifically for blood establishments | SAME |
| Interpretation | Makes no decision about which antibodies are present. It helps the technologist select the best red cells for testing, analyze which antibodies are ruled out and decide which antibodies are present. | SAME |
| Reagent data | Reagent data is updated by the submitter from data sheets provided with each new lot of reagent cells distributed by the original manufacturers. | SAME |
| Displayed results | Shows which antibodies are ruled out based on negative test results for both homozygous and heterozygous positive antigens on reagent cells, and displays a count of these rule-outs. | SAME |
| Results management | The software's results are repeatable so a reviewer may check the technologists' work and decisions. | SAME |
| Audit trail | Audit trail of processing steps and user actions | SAME |
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IMMUCOR®
| Characteristic / Feature | Bio-Rad IH-AbID Integrated Antibody Identification | Modified Device: ImmuLINK (v3.0) |
| --- | --- | --- |
| Intended Use | IH-AbID Integrated Antibody Identification Software is an optional software module for IH- Com that provides the user with guidance and information on the identification of antibodies to red blood cell antigens subsequent to the immunohematology testing with the IH-system. For use by trained laboratory personnel, in a blood banking environment | 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). |
### 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 antibody exclusion (rule-out) capabilities for Capture-R results [with the Antibody ID feature].
Immucor concludes, based on the indications for use, technological characteristics, and performance testing, that modified ImmuLINK with Antibody ID is safe and effective for the intended use described above.
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