Erytra Eflexis

{0} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5 - 1 ## Section 5 – 510(k) Summary ### Submitter’s Details: Name Diagnostic Grifols S.A. Address Passeig Fluvial, 24, Parets del Valles Barcelona, 08150, Spain Establishment Registration 3002772505 Number: Contact Person: Elvira Estapé Egea Regulatory Affairs Manager elvira.estape@grifols.com Phone: (34) 670-922-237 Date of Summary: March 29th, 2023 ### Name of Device: Trade Name: Erytra Eflexis Classification Name: Automated Blood Grouping and Antibody Test System Device Class: II Product Code: KSZ Regulation Number: 21 CFR 864.9175 ### Identification of the Legally Marketed Device (Predicated Device): Trade Name: Erytra Eflexis Classification Name: Automated Blood Grouping and Antibody Test System 510(k) Number: BK220752 Device Class: II Product Code: KSZ Regulation Number: 21 CFR 864.9175 Clearance Letter November 1, 2022 ### Device Description: Erytra Eflexis is designed to automate all necessary operations and procedures to process gel immunohematology tests, allowing laboratories to: 1. Create test profiles and optimize profile implementation in the shortest time and with the most accurate results. 2. Increase process safety and traceability by eliminating possible identification and transcription errors. 3. Increase analytical reliability by standardizing all steps, eliminating possible handling and processing errors, and interpreting the results with objective criteria. 4. Reduce the danger of contamination for operators by reducing operator interaction with {1} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5 - 2 the samples and reagents during the analytical process. Operator interaction is limited to the loading and unloading of the analyzer. In addition, Erytra Eflexis adapts to the needs and differing operational workflows in immunohematology laboratories, donation centers, transfusion centers, and clinical testing laboratories, as well as different work rhythms (routine, emergency) and the flow of samples processed over different shifts. Erytra Eflexis automates the following gel immunohematology tests: - ABO Red Cell and Serum Grouping. Rh(D) Typing. Antigen Typing. Antibody detection. Antibody identification. Antibody titration. - Direct Antiglobulin test. - Compatibility Tests (Crossmatching). # **Indications for Use:** Erytra Eflexis is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer's Laboratory Information System (LIS), Erytra Eflexis automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. {2} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5-3 Comparison to Predicate Device: | Parameter | Predicate Device Diagnostic Grifols S.A. Erytra Eflexis with software version 1.2.5 (BK220752) | Subject Device Diagnostic Grifols S.A. Erytra Eflexis with new software version 3.0.0 | | --- | --- | --- | | General | | | | Indications for Use Statement | Erytra Eflexis is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), Erytra Eflexis automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. | Erytra Eflexis is a fully-automated analyzer designed to automate in vitro immunohematological testing of human blood utilizing DG Gel 8 cards technology, including Blood Grouping, Antigen Typing, Antibody Screening, Antibody Identification, Antibody Titration, Compatibility Tests, and Direct Antiglobulin Tests. As a standalone analyzer or interfaced to the customer’s Laboratory Information System (LIS), Erytra Eflexis automates test processing functions and data management requirements using DG Gel 8 cards and digital image processing. | | Classification | II | II | | Product Code | KSZ | KSZ | | Regulation number | 21 CFR 864.9175 | 21 CFR 864.9175 | | Common name | Automated Blood Grouping and Antibody Test System | Automated Blood Grouping and Antibody Test System | | Test performed | - ABO Red Cell and Serum Grouping - Rh(D) Typing - Antigen Typing - Antibody detection - Antibody identification - Antibody titration - Direct Antiglobulin test - Compatibility Tests (Crossmatching) | - ABO Red Cell and Serum Grouping - Rh(D) Typing - Antigen Typing - Antibody detection - Antibody identification - Antibody titration - Direct Antiglobulin test - Compatibility Tests (Crossmatching) | | Primary components | Analyzer Computer Software Optional hand-held bar code scanner Optional printer | Analyzer Computer Software Optional hand-held bar code scanner Optional printer | | Specimen Types | Plasma, Serum and Red Blood Cells. | Plasma, Serum and Red Blood Cells. | {3} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5 - 4 | Parameter | Predicate Device Diagnostic Grifols S.A. Erytra Eflexis with software version 1.2.5 (BK220752) | Subject Device Diagnostic Grifols S.A. Erytra Eflexis with new software version 3.0.0 | | --- | --- | --- | | **Reagents** | Erytra Eflexis is used with Diagnostic Grifols DG Gel 8 cards, Medion Grifols Diagnostics Reagent Red Blood Cells and Validated Antisera Reagents. | Erytra Eflexis is used with Diagnostic Grifols DG Gel 8 cards, Medion Grifols Diagnostics Reagent Red Blood Cells and Validated Antisera Reagents. | | **Positive identification of samples and reagents** | Yes | Yes | | **Throughput** | 36 samples (ABO/Rh cards) per hour, including forward & reverse group | 36 samples (ABO/Rh cards) per hour, including forward & reverse group | | **Useful life** | 7 years, considering 8 hours a day of continuous operation at maximum throughput (using ABO/Rh DG Gel 8 cards), 250 days a year. | 7 years, considering 8 hours a day of continuous operation at maximum throughput (using ABO/Rh DG Gel 8 cards), 250 days a year. | | **Hardware** | | | | **Reagent Red Cell suspension** | Maintained by Rotation Movement | Maintained by Rotation Movement | | **Barcode Symbologies** | - Interleaved 2 of 5. - Code 3 of 9. - Codabar. - EAN 8 / EAN 13 / JAN 8 / JAN 13. - Codes 128 A, B & C (ISBT 128). - Others under configuration. | - Interleaved 2 of 5. - Code 3 of 9. - Codabar. - EAN 8 / EAN 13 / JAN 8 / JAN 13. - Codes 128 A, B & C (ISBT 128). - Others under configuration. | | **Sample loading capacity** | 72 tubes simultaneously | 72 tubes simultaneously | | **Reagent loading capacity** | 2 removable, independent and random-access racks. | 2 removable, independent and random-access racks. | | **Sample/Reagent Dispensing (pipetting) Unit** | 1 | 1 | | **Card loading capacity** | 200 cards | 200 cards | | **Incubator** | 3 independent incubators | 3 independent incubators | | **Centrifuge** | 2 independent centrifuges | 2 independent centrifuges | | **System solution and waste containers** | 1 container for Grifols Wash Solution A 1 container for Grifols Wash Solution B 2 containers for waste solutions that can be configured to become Wash Solution containers if external drain is used. 1 disposable container for processed DG Gel 8 cards | 1 container for Grifols Wash Solution A 1 container for Grifols Wash Solution B 2 containers for waste solutions that can be configured to become Wash Solution containers if external drain is used. 1 disposable container for processed DG Gel 8 cards | {4} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5-5 | Parameter | Predicate Device Diagnostic Grifols S.A. Erytra Eflexis with software version 1.2.5 (BK220752) | Subject Device Diagnostic Grifols S.A. Erytra Eflexis with new software version 3.0.0 | | --- | --- | --- | | Firmware/Software | | | | Operating System | Microsoft Windows 10 IoT Enterprise | Microsoft Windows 10 IoT Enterprise | | Software version | 1.2.5 | 3.0.0 | | Software applications | Executor, Manager, Importer, Technical Service, Diagnostic, System Tools and Diana Server. | Eflexis, Importer, Technical Service, Diagnostic, System Tools and Diana Server. | | Interfaced with Laboratory Information System (LIS) | Yes - Unidirectional. - Bidirectional. | Yes - Unidirectional. - Bidirectional. | | Capability to process STAT samples | Yes | Yes | | QC procedures implemented | Yes | Yes | | Manual Entry of Sample IDs | Requires Double Blind Entry | Requires Double Blind Entry | | Incubator temperature | Incubators can be set up independently at 37°C or 24°C. Temperature accuracy at 37°C: ±1°C Temperature accuracy at 24°C: ±3°C | Incubators can be set up independently at 37°C or 24°C. Temperature accuracy at 37°C: ±1°C Temperature accuracy at 24°C: ±3°C | | Relative centrifugal force | 127g +/- 12g at 4.6mm from the bottom of the microtube. | 127g +/- 12g at 4.6mm from the bottom of the microtube. | | Centrifugation time | 9.0 minutes +/- 0.5min (measured from the starting to accelerate moment to the starting to brake moment). | 9.0 minutes +/- 0.5min (measured from the starting to accelerate moment to the starting to brake moment). | | Automated results reading | Yes. Microtube Digital Image Analysis. | Yes. Microtube Digital Image Analysis. | | Automated test interpretation | Yes. According to predefined rules stated in a definition file. | Yes. According to predefined rules stated in a definition file. | | Access control | User access limited to authorized individuals with specific privileges. Every user is unique and has a user identifier and specific password. User's passwords are encrypted. Complies with 21CFR11. | User access limited to authorized individuals with specific privileges. Every user is unique and has a user identifier and specific password. User's passwords are encrypted. Complies with 21CFR11. | | Barcode Reading | Sample Identification Reagent Lot N°. and Expiration Date | Sample Identification Reagent Lot N°. and Expiration Date | {5} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5 - 6 ## Main functionalities introduced with software version 3.0.0 The new software version 3.0.0 introduces both new functionalities, major architecture changes and resolution of defects and complaints. The main functionalities are described in Section 16 - Software. A detailed Revision History table including all changes from version 1.2.5 to 3.0.0 is included in Attachment 1. The main functionalities introduced in software version 3.0.0 are: - Implement use of Adobe AIR technology - To create one single application for Manager and Executor applications - Implement reagents stability on board functionality - Implement the new planification of techniques in incubators and centrifuges - Implement the management of reusable cards area - Modify the decontamination process of the instrument - Modify Eflexis Diagnostic application - Improve the communication with LIS - Implement new Backup and Restore applications ## Performance: Verification and Validation activities were conducted following the instruction DI.INS.301_ING “Life and Cycle and Software Validation”. Regression analysis and Verification testing data showed no impact on the instrument’s performance characteristics by the changes described in this submission. ## Conclusions: Diagnostic Grifols S.A. concludes, based on all the information submitted and discussed in this submission and in this summary that Erytra Eflexis with the new software version 3.0.0, when used for the defined indications for use, performs as well as or better than the legally marketed predicate device Erytra Eflexis (BK220752) running under software 1.2.5.