**IMMUCOR Match It Antibody Software User Guide

**

Section 5.0 510(k) Summary – MATCH IT! ® Antibody software version 1.5

Submitter

Owner/Manufacturer:| Immucor GTI Diagnostics, Inc.
Address:| 20925 Crossroads Circle
Waukesha, WI 53186
USA
Phone:| 262.754.1011
Fax:| 262.754.1078
Contact Person:| Anna Rachfalska (arachfalska@immucor.com)
Date Prepared:| 8-30-2022
Name   Of Device
Device Trade Name:| MATCH IT! ® Antibody
version 1.5
Common Name:| MATCH IT! ® Antibody software
Classification Name:| Test, Qualitative, For HLA, Non-Diagnostic
Division:| CBER
Review Panel:| Hematology
Product Code:| MZI
Classification:| Unclassified
Submission Type:| Special 510(k)
Regulatory Class (Device Class):| : Class II

5.3 Name Of Predicate Device For Claiming Equivalence

MATCH IT! ® Antibody software 1.4 (BK210572)

5.4 Device Description
MATCH IT!® Antibody software is an optional accessory to aid in the evaluation of test results from Immucor GTI Diagnostics, Inc. LIFECODES® Antibody detection kits for use with Luminex. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any result to ensure correctness.

The software is a computer program designed to analyze the raw data coming from the Luminex Fluoroanalyzer after running the LIFECODES® Antibody assays. The software consists of one installation USB device, a User’s Manual and a Quick Reference Guide. Install Instructions and Release notes are also available.

Applicable LIFECODES® Antibody detection kits are listed in the MATCH IT!® Antibody software Quick Reference Guide.

The MATCH IT!® Antibody software is designed to analyze the raw data coming from the Luminex Fluoroanalyzer when used with LIFECODES® Antibody detection Kits. The raw data is in csv file format and consists of the Median Fluorescent Intensity (MFI) values for each bead in an assay. The relative signal (MFI) obtained with the probes/bead in the LIFECODES® assays can be used to assign the probes/bead as having positive or negative reactivity. This in turn provides the information needed to determine antibody assignments. The generated csv files can be imported and the data processed with the MATCH IT!® Antibody software. The calculations and subsequent analysis performed by the software are outlined in the MATCH IT!® Antibody software User’s manual and the Instructions for Use of the LIFECODES® Antibody detection Kits.

The MATCH IT!® Antibody software is intended to assist qualified laboratory personnel. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any clinical or diagnostic result to ensure correctness. The software is a laboratory aid and not meant to be the sole source of
a definitive result.
The software consists of one installation USB, Quick Reference guide, and a user’s manual.
Proposed Change:
New functionality: LifeScreen XP, Non-HLA (RUO) products, added detailed graph for LSA, and improved epitope analysis functionality.

5.5 INDICATIONS FOR USE

5.5.1 Intended Use:
MATCH IT! Antibody software is an optional accessory to aid in the evaluation of test results from Immucor GTI Diagnostics, Inc. LIFECODES Antibody detection kits for use with Luminex. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any result to ensure correctness. For In Vitro Diagnostic (IVD) Use.

5.5.2 Indications for Use:
MATCH IT! Antibody software v1.5 is an optional accessory to the following LIFECODES
antibody detection kits for use with Luminex:

Software Models
The software will include the products described below for each model of the software.

Default settings for all assays are aligned with the IFU and the performance characteristics of the assay. Any other methods of assignment would need to be validated by lab personal prior to use.

The software is intended for In vitro diagnostic us

Documentation to support the software versions are as follows:

1. User Manual; one version
   a. IVD LC1684IVD

2. Quick Reference Guides (QRG)
   a. LC1686EN
   The User Manuals and Quick Reference Guides are translated into the languages required for the markets the software is distributed to.

5.6 Substantial Equivalence
The Intended Use of the software is not changing. The software is not intended for prescription or over-the-counter use. The software is used in clinical laboratories where patient, blood donor and 0transplant associated testing is performed.

Within the submission, the studies performed to verify the modifications made to the MATCH IT! ® Antibody Software are being provided. The modification of the software being presented in this submission is the compilation and verification of new functionality LifeScreen XP, non-HLA products, added detailed graph for LSA, and Improved epitope analysis functionality. Detailed graphs for LSA

  and improved epitope analysis functionalities are being added to aid the qualified laboratory in personal in assessing the patterns of reactivity observed. LIFECODES Life Screen XP is part of LIFECODES Life Screen Deluxe. XP has two extra beads and functions exactly the same as Deluxe, so there was no need to have a separate section in the manual.

• The proposed revision of the MATCH IT! Antibody Software User Manual Instructions and Quick Reference Guide are provided in the labeling section. The Quick Reference Guide is available to users to supplement the User Manual.
• Clarification of the product name is being provided as MATCH IT!® Antibody Software.

5.6.1 Summary of Similarities and Differences between the MATCH IT! ® Antibody
Software v1.4 and the MATCH IT! ® Antibody Software v1.5. Similarities between the MATCH IT!® Antibody Software v1.4 and the MATCH IT!® Antibody Software v1.5:

• The Intended Use has not changed between versions of the software.
• The algorithm applied to the LifeScreen XP is identical to the existing algorithm for LifeScreen Deluxe. There are no functionality changes that would impact the results supplied by the software. LSA graph and epitope analysis tools have been updated. The updated functionality would not impact the results supplied by the software.
• There are no changes to the algorithm applied for the LIFECODES assay products.

Differences between the MATCH IT! ® Antibody Software v1.4 and the MATCH IT!® Antibody
Software v1.5:
The changes have been updated as described in the table below.
The table below provides the comparison between the MATCH IT!® Antibody software v1.5 and
the predicate device.

#| ELEMENT/ FEATURE| PREDICATE DEVICE| CANDIDATE DEVICE| Comments
---|---|---|---|---
1| Trade Name| MATCH IT!® Antibody software v1.4| MATCH IT!® Antibody software v1.5| —
2| Manufacturer| Immucor GTI Diagnostics, Inc.| Immucor GTI Diagnostics, Inc.| —
3| Intended Use| MATCH IT! ® Antibody| MATCH IT! ® Antibody| No Difference
software v1.4 is an| software v1.5 is an
optional accessory to aid| optional accessory to aid
in the evaluation of test| in the evaluation of test
results from Immucor GTI| results from Immucor
Diagnostics, Inc.| GTI Diagnostics, Inc.
LIFECODES® Antibody| LIFECODES® Antibody
detection kits for use with| detection kits for use
Luminex. Due to the| with Luminex. Due to the
complex nature of HLA| complex nature of HLA
Testing, qualified| Testing, qualified
laboratory personnel must| laboratory personnel
review any result to| must review any result to
ensure correctness.| ensure correctness.
4| Indications for Use| MATCH IT! ® Antibody software v1.4 is an optional accessory to the following LIFECODES| MATCH IT! ® Antibody software v1.5 is an optional accessory to the following LIFECODES| Upgraded Requirement
antibody detection kits for use with Luminex: LIFECODES® Class I ID LIFECODES® Class II IDv2LIFECODES® LifeScreen DeluxeLIFECODES® LSA Class ILIFECODES® LSA Class IIDefault settings for all assays are aligned with the IFU and the performance characteristics of the assay. Any other methods of assignment would need to be validated by lab personal prior to use.| antibody detection kits for use with Luminex: LIFECODES® Class I ID LIFECODES® Class II IDv2 LIFECODES®LifeScreen Deluxe LIFECODES® LSA Class ILIFECODES® LSA Class IILIFECODES LifeScreen XPDefault settings for all assays are aligned with the IFU and the performance characteristics of the assay. Any other methods of assignment would need to bevalidated by lab personal prior to use.|
5| Software Environment| The software is designed to work in a centralized database environment on a network, or in a standalone configuration on your computer.| The software is designed to work in a centralized database environment on a network, or in a standalone configuration on your computer.| No Difference
6| Hardware and Software Minimum Requirements| Microsoft® Windows 10 operating systems| Microsoft® Windows 10 operating systems| No Difference
.NET Framework Version4.6 (Included with software)| .NET Framework Version 4.6 (Included with software)| No Difference
Microsoft® SQL Server 2016 Express (Included with software)| Microsoft® SQL Server 2016 Express (Included with software)| No Difference
2.33 GHz or faster 64-bit processor| 2.33 GHz or faster 64-bit processor| No Difference
50 GB hard disk space| 50 GB hard disk space| No Difference
8 GB RAM| 8 GB RAM| No Difference
DirectX 9 or later graphics card with WDDM 1.0 driver| DirectX 9 or later graphics card with WDDM 1.0 driver| No Difference
XGA display with 1024 x 768| XGA display with 1024 x 768| No Difference
A mouse or other Windows compatible point device| A mouse or other Windows compatible point device| No Difference
A Windows compatible printer driver| A Windows compatible printer driver| No Difference
7| Data Import Requirements| Designed to import csv files created by the Luminex x PONENT software| Designed to import csv files created by the Luminex xPONENT software| No Difference
Luminex is running software versions x PONENT 3.1, 4.2, or 4.3| Luminex is running software versions xPONENT 3.1, 4.2, or4.3| No Difference
The batch name cannot be reused and cannot exceed 30 characters including spaces.| The batch name cannot be reused and cannot exceed 30 characters including spaces.| No Difference
The data present in the csv file must be generated using an unmodified Luminex template that is providedby Immucor GTI Diagnostics.| The data present in the csv file must be generated using an unmodified Luminex template that is providedby Immucor GTI Diagnostics.| No Difference
8| Data Analysis| Analyze the raw data and review the results in graphical form.| Analyze the raw data and review the results in graphical form.| No Difference
Adjust Cut-off values to clarify the results.| Adjust Cut-off values to clarify the results.| No Difference
Easily update product information| Easily update product information| No Difference
Search for specific data| Search for specific data| No Difference
9| Reporting| Create standard reports| Create standard reports| No Difference
Create custom reports| Create custom reports| No Difference
10| UDI| 10888234500810| 10888234500810| No Difference

Similarities between the MATCH IT! ® Antibody software v1.5 and MATCH IT!® Antibody software
v1.4

1. MATCH IT!® Antibody software v1.5 and MATCH IT!® Antibody software v1.4 have same intended use and indications for use.
2. MATCH IT!® Antibody software v1.5 and MATCH IT!® Antibody software v1.4 utilize raw data from the Luminex instrument employing same bead based Luminex Assay technology and same assay steps.
3. MATCH IT!® Antibody software v1.5 and MATCH IT!® Antibody software v1.4 work in the same software environment.

Differences between the MATCH IT!® Antibody software v1.5 and MATCH IT!® Antibody software v1.4

The differences between the predicate device and the candidate device reflect the addition of LIFECODES LifeScreen XP. The algorithm wasn’t changed. The advances in the technological capabilities of the subject device reflect the most current technology that exists to allow performance to current industry standards. The new features do not raise any new questions of safety or effectiveness of the subject device when compared to the predicate.
5.7 Comparison Of Technological Characteristics With The Predicate Device (Substantial Equivalence).

Electrical safety and electromagnetic compatibility (EMC):
Luminex’s Technical Files include Declarations of Conformity to the ECD (Electromagnetic Compatibility Directive) 86/336/EEC and the LVD (Low Voltage Directive) 73/23/EEC for the Fluoroanalyzer, XYP (96 plate accessory) and sheath delivery system.

Software Verification and Validation Testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA’s Guidance for Industry and FDA Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.”

Nonclinical tests submitted:
Independent nonclinical performance studies are not required for the software as the software cannot be utilized as a stand-alone device.

Clinical tests submitted:
Independent clinical performance studies are not required for the software as the software cannot be utilized as a stand-alone device. Verification of the software to produce the same calculations, as manual methods have been completed for LIFECODES HLA Antibody assays. User Acceptance Testing has also been completed. The software meets the provisions of the standard IEC 62304, Software Life-cycle Processes.

For the prior software version, MATCH IT! Antibody software v1.4, Validations

370 and #475 verified that the software can provide the same results as the

manual calculations indicated in the product insert and thus validated the software’s intended use.

Software-related Documentation:
The following guidance documents issued by the agency have been referenced during preparation of this Traditional 510(k) submission:

5.7.1 Content of Pre-Market Submissions for Software Contained in Medical Devices.
The device is categorized as Moderate Concern. The following documentation is being provided related to the device modification being proposed:

Software Documentation| Requirement for Moderate Concern devices| Included Yes/No| Explanation
---|---|---|---
Level of Concern| A statement indicating the Level of Concern and a description of the rational for that level.| Yes| NA
Software Description| A summary overview of the features and software operating environment| Yes| NA
Risk Management (Device Hazard Analysis)| Tabular description of identified hardware and software hazards, including severity assessment and mitigations| Yes| NA
Software Requirements Specification (SRS)| The complete SRS document| Yes| NA
Architecture Design Chart| Detailed depiction of functional units and software modules. May include state diagrams as well as flow charts.| Yes| NA
Software Design Specification (SDS)| Software design specification document.| Yes| NA
Traceability Analysis| Traceability among requirements, specifications, identified hazards and mitigations, and Verification andValidation testing.| Yes| NA
Software Development Environment Description| Summary of software life cycle development plan, including a summary of the configuration management and maintenance activities.| Yes| NA
Verification and Validation Documentation| The Verification and Validation of the software modification is a part of the Functional, Scenario, UAT and Installation Testing.| Yes| See Functional, Scenario, UAT andInstallation Testing.
Revision Level History| Revision history log, including release version number and date.| Yes| NA
Unresolved Anomalies (Bugs or Defects)| List of remaining software anomalies, annotated with an explanation of the impact on safety or effectiveness, including operator usage and human factors.| Yes| NA
Off-the-Shelf Software| Not defined. Include in Software Description.| Yes| NA
Detailed Functional Test Results| Applies to Verification and Validation Documentation.| Yes| NA
Scenario Test Report| Applies to Verification and Validation Documentation.| Yes| NA
User Acceptance Test Documentation| Applies to Verification and Validation Documentation.| Yes| NA
Installation Test Report| Applies to Verification and Validation Documentation.| Yes| NA

5.7.2 Studies supporting safety and effectiveness of the candidate device
MATCH IT!® Antibody software v1.5 is being submitted to be usable on 64-bit computer systems as an IVD product for the US market. Unit testing as described below presents Verification and Validation of the software. The Verification and Validation of the software is a part of the Functional, Scenario, UAT and Installation Testing.

Section 18.0, Performance Testing-Bench presents the Master Test Plan which defines the   verification requirements and provides evidence that the MATCH IT!® Antibody was designed, installed, and tested in accordance with its intended use and is in compliance wit quality software engineering principles. The following sub-system test types evaluated individual components of the software:

• Functional Testing
• Scenario Testing
• Full System Testing
• User Acceptance Testing
• Installation Testing

The reports for each of these testing studies are provided in Section 21.0, Software.

5.7.3 Management of Cybersecurity in Medical Devices
The guidance “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” was used to define the evaluation of cybersecurity threats and vulnerabilities associated with the MATCH IT!® Antibody software v1.5. The following activities were performed:

Vulnerability Assessment of MATCH IT! ® Antibody software and bundled applications

• Threat Modeling
• Cybersecurity Risk Assessment of MATCH IT! ® Antibody software
• Cybersecurity Guidance Document for MATCH IT! ® Antibody software
• MDS2 for MATCH IT! ® Antibody software

A Vulnerability Assessment report identified findings related to MATCH IT!® Antibody software v1.5. The level of risk associated with the findings were categorized as high, medium, low and informational. Cybersecurity Risks identified during the cybersecurity risk assessment are mitigated or reduced using Cybersecurity Controls to an acceptable level.

A Cybersecurity Guidance Document for MATCH IT! ® Antibody software has been prepared which will be provided to users describing steps to implement to reduce cybersecurity risks.

5.7.4. Human Factors and Usability Engineering in Medical Devices
The two guidance documents, listed below, were applied to the Human Factors and Usability Engineering assessment which generated a statement on non- application based on the following points:

• The criteria for requiring the application of a human factors and usability engineering process to a medical device such as the MATCH IT!® Antibody Software product is the possibility of causing serious harm to a patient or user.
• Users performing tasks incorrectly or failing to perform tasks using the MATCH IT!® Antibody software product cannot result in serious harm to the patient or user.
• MATCH IT!® Antibody software is not included on the high priority list of devices.
• Review of five points for consideration of non-high priority list devices, did not identify conditions which would require inclusion in premarket submission.
• The application of a human factors and usability engineering process as defined by the
  FDA guidance is not required for the MATCH IT!® Antibody software product. Human factors data does not need to be provided in the FDA submission.

Guidance documents applied to Human Factors and Usability Assessment

Applying Human Factors and Usability Engineering to Medical Devices| February 3, 2016| Guidance for Industry and Food and Drug Administration Staff
---|---|---
List of Highest Priority Devices for Human Factors Review| February 3, 2016| Draft Guidance for Industry and Food and Drug Administration Staff

Summary:
Based on the clinical performance as documented in the pivotal clinical study, the MATCH IT! Antibody software v1.5 was found to have a safety and effectiveness profile that is similar to the predicate device. 5.8 Conclusions
Based on the Verification activities and Cybersecurity Assessment results, the assessments and data demonstrate that the MATCH IT!® Antibody software does not present issues of safety and effectiveness.

MATCH IT! Antibody software 510(k) Summary

Documents / Resources

| IMMUCOR Match It Antibody Software [pdf] User Guide
PN 628200 IFU LC807IVD, PN 628223 IFU LC807IVD, PN 628215 IFU LC1003IVD, PN 265100IVD IFU LC1683IVD, PN 265200IVD IFU LC1683IVD, PN 628220 IFU LC1698IVD, Match It Antibody Software, Antibody Software, Software
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