← Product Code [MZI](/productcode/MZI) · BK241067 # MatchX (BK241067) _Immucor GTI Diagnostics, Inc. Waukesha, WI · MZI · Jan 2, 2025 · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/BK241067 ## Device Facts - **Applicant:** Immucor GTI Diagnostics, Inc. Waukesha, WI - **Product Code:** [MZI](/productcode/MZI.md) - **Decision Date:** Jan 2, 2025 - **Decision:** SESE - **Device Class:** Class U - **Attributes:** Software as a Medical Device ## Indications for Use MatchX Software is an accessory to aid in the evaluation of test results from Immucor GTI Diagnostics, Inc. LIFECODES® Antibody Detection kits and LIFECODES® HLA-SSO Typing kits for use with Luminex® instruments. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any result to assure correctness. ## Device Story MatchX software; accessory for Immucor LIFECODES HLA antibody detection/typing kits; processes raw CSV data (Median Fluorescent Intensity values) from Luminex Fluoroanalyzer; performs calculations per kit-specific Instructions for Use (IFU); assigns positive/negative reactivity to probes/beads; determines antibody assignments or suggests HLA alleles; used in clinical laboratories by qualified personnel; software acts as laboratory aid; results require manual review by qualified personnel to ensure correctness; not intended as sole source of definitive diagnostic results. ## Clinical Evidence No clinical trials performed. Bench testing only. Verification activities confirmed software calculations match manual methods for LIFECODES HLA Antibody and HLA-SSO assays. User Acceptance Testing (UAT) completed. Software developed in compliance with IEC 62304. ## Technological Characteristics Software-based accessory; processes CSV data files containing MFI values; utilizes rule-based analysis methodology defined in LIFECODES product inserts; standalone software application; developed per IEC 62304 software life-cycle processes; includes cybersecurity controls. ## Predicate Devices - MATCH IT! Antibody Software ([BK220762](/device/BK220762.md)) - MATCH IT! DNA Software ([BK190439](/device/BK190439.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [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/). {0} werfen Immucor GTI Diagnostics, Inc # 510(k) Summary – MatchX software In accordance with 21 CFR 807.87(h), a 510(k) summary is included that meets the conditions as outlined for a 510(k) summary in 21 CFR 807.92. # Submitter Information: Owner/Manufacturer: Immucor GTI Diagnostics, Inc. Address: 20925 Crossroads Circle Waukesha, WI 53186 USA # Official Correspondence regarding this 510(k): Name Amy Cochran Manager, Regulatory Affairs / Quality Assurance Address: 20925 Crossroads Circle Waukesha, WI 53186 USA Phone: 262.754.1011 Email acochran@werfen.com # Device: Device Classification Name: Test, Qualitative, For HLA, Non-Diagnostic Trade Name: MatchX (888628) Common Name: MatchX Software Review Panel: Hematology Classification Product Code: MZI Device Classification Regulation: N/A Device Class: Class II Predicate Devices | Predicate | Trade Name | Manufacturer | 510(k) Number | Classification Product Code | | --- | --- | --- | --- | --- | | MATCH IT! Antibody Software | MATCH IT! Antibody Software | Immucor GTI Diagnostics, Inc. | BK220762 | MZI | | MATCH IT! DNA Software | MATCH IT! DNA Software | Immucor GTI Diagnostics, Inc. | BK190439 | MZI | Confidential BK241067 MatchX 510(k) Summary {1} werfen Immucor GTI Diagnostics, Inc # Device Description Summary MatchX Software is an accessory to aid in the evaluation of test results from Immucor GTI Diagnostics, Inc. LIFECODES® Antibody Detection kits and LIFECODES® HLA-SSO Typing kits for use with Luminex® instruments. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any result to assure correctness. # Principles of the Procedure The MatchX Software is designed to analyze the raw data coming from the Luminex Fluoroanalyzer when used with LIFECODES 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 for Antibody Detection kits or suggested alleles for HLA SSO Typing kits. The generated csv files can be opened and the data processed with the MatchX Software. The calculations and subsequent analysis performed by MatchX software are outlined in the Instructions for Use of the LIFECODES Kits. The MatchX 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 assure correctness. The software is a laboratory aid and not meant to be the sole source of a definitive result. The MatchX software utilizes the analysis methodology set forth in the LIFECODES products Product Inserts. | LIFECODES Product | Product Insert Document Number | | --- | --- | | LIFECODES Class I ID | LC807IVD | | LIFECODES Class II ID v2 | | | LIFECODES LifeScreen Deluxe | LC1003IVD | | LIFECODES LifeScreen XP | LC1698IVD | | LIFECODES LSA Class I | LC1683IVD | | LIFECODES LSA Class II | | | LIFECODES HLA-A eRES SSO Typing Kit | LC1436IVD | | LIFECODES HLA-B eRES SSO Typing Kit | | | LIFECODES HLA-C eRES SSO Typing Kit | | | LIFECODES HLA-DRB1 eRES SSO Typing Kit | | | LIFECODES HLA-DRB3,4,5 SSO Typing Kit | | | LIFECODES HLA-DQA1/B1 SSO Typing Kit | | | LIFECODES HLA-DPA1/B1 SSO Typing Kit | | # Intended Use / Indications for Use: MatchX Software is an accessory to aid in the evaluation of test results from Immucor GTI Diagnostics, Inc. LIFECODES® Antibody Detection kits and LIFECODES® HLA-SSO Typing kits for use with Luminex® instruments. Due to the complex nature of HLA Testing, qualified laboratory personnel must review any result to assure correctness. Confidential BK241067 MatchX 510(k) Summary {2} werfen Immucor GTI Diagnostics, Inc MatchX is an optional accessory to the following LIFECODES Antibody detection kits and LIFECODES HLA-SSO Typing Kit for use with Luminex: | LIFECODES® LifeScreen Deluxe | (PN 628215) | | --- | --- | | LIFECODES® LifeScreen XP | (PN 628220) | | LIFECODES® Class I ID | (PN 628200) | | LIFECODES® Class II ID v2 | (PN 628223) | | LIFECODES® LSA Class I | (PN 265100IVD) | | LIFECODES® LSA Class II | (PN 265200IVD) | | LIFECODES® HLA-A eRES SSO Typing Kit | (PN 628913) | | LIFECODES® HLA-B eRES SSO Typing Kit | (PN 628917) | | LIFECODES® HLA-C eRES SSO Typing Kit | (PN 628921) | | LIFECODES® HLA-DRB1 eRES SSO Typing Kit | (PN 628925) | | LIFECODES® HLA-DRB 345 SSO Typing Kit | (PN 628927) | | LIFECODES® HLA-DQA1/B1 SSO Typing Kit | (PN 628930) | | LIFECODES® HLA-DPA1/B1 SSO Typing Kit | (PN 628936) | 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 (IVD) Use. # Non-Clinical / Clinical Trials Independent non-clinical / 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 and LIFECODES HLA-SSO assays. User Acceptance Testing has also been completed. The software meets the provisions of the standard IEC 62304, Software Life-cycle Processes. # Summary of Safety and Effectiveness The MatchX software was developed in accordance with relevant regulations. The software was thoroughly tested, including Functional, Scenario, UAT, Installation Testing and Cybersecurity to ensure it was adequately developed and functioned according to its intended use. Based on the Verification activities and Cybersecurity Assessment results, the assessments and data demonstrate that the MatchX software does not present issues of safety and effectiveness. Confidential BK241067 MatchX 510(k) Summary --- **Source:** [https://fda-staging.innolitics.com/device/BK241067](https://fda-staging.innolitics.com/device/BK241067) **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