Erytra Eflexis

{0} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5 - 1 # **CH2.03 – 510(k) Summary** # **Contact 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: June 13th, 2025 # **Device Name:** 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 # **Legally Marketed Predicate Device:** Trade Name: Erytra Eflexis Classification Name: Automated Blood Grouping and Antibody Test System 510(k) Number: BK230820 Device Class: II Product Code: KSZ Regulation Number: 21 CFR 864.9175 Clearance Letter June 22, 2023 # **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. {1} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5 - 2 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 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 (BK230820) | Subject Device Diagnostic Grifols S.A. Erytra Eflexis | | --- | --- | --- | | **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 (including Single Point and Range Titration techniques) - 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. | | **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. | {3} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5 - 4 | Parameter | Predicate Device Diagnostic Grifols S.A. Erytra Eflexis (BK230820) | Subject Device Diagnostic Grifols S.A. Erytra Eflexis | | --- | --- | --- | | **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 The differences between the Erytra Eflexis and its predicate device, the Erytra Eflexis (BK230820), are related to the Antibody Titration technique. The Erytra Eflexis uses an automated serial dilution method that allows for the preparation of dilutions up to 1/2048. Additionally, the Erytra Eflexis supports both single point and range titration techniques within antibody titration tests, when required by the user, in comparison to the predicate device. These differences do not raise new concerns of safety and effectiveness. **Performance:** All new risks and hazard analysis related to the automated serial dilution method, and single dilution and range titration techniques, have been performed and documented per ISO 14971 guidelines. An in-house method comparison study was conducted with three Erytra Eflexis, and with DG Gel 8 Anti-IgG (Rabbit) and DG Gel 8 Neutral cards, and 0.8% Reagent Red Blood Cells. The following methods were used as comparative methods: - Serial dilution titration technique: the current FDA approved automated single direct dilution method was used as comparative for titers up to 64, and the manual serial double dilution method was used as comparative for titers higher than 64. - Single dilution and range titration techniques: the manual serial double dilution method was used as comparative for high range titrations. A total of 246 titrations were compared for serial dilution titration techniques and out of 76 samples were used for range titration techniques comparison. Additionally, a total of 364 single dilution tests were compared with the manual method. The percent agreements and the lower limits of 95% one-side confidence interval (CI) for Erytra Eflexis and antibody titration technique are indicated in the following table: | Antibody Titration | N° of samples | Percent Agreement (Lower 95% CI) | | --- | --- | --- | | **Concordances Obtained for Anti-Human Globulin** | | | | Serial Dilution Technique | 116 | 100% (97.5%) | | Ranges Technique | 76 | 100% (96.1%) | | Single Point | 205 | 100% (98.5%) | | **Concordances Obtained for the Neutral Gel** | | | | Serial Dilution Technique | 130 | 99.2% (96.4%) | | Ranges Technique | 76 | 100% (96.1%) | | Single Point | 159 | 100% (98.1%) | {5} Diagnostic Grifols, S.A. 510(k) Premarket Notification Erytra Eflexis 5 - 6 The percent agreement (estimated with a 95% CI) between the three antibody titration techniques performed by Erytra Eflexis and with the respective comparative methods met all the acceptance criteria previously established as $\geq 95\%$ for DG Gel 8 Anti-IgG (Rabbit) and for DG Gel 8 Neutral cards. The results obtained in the Method comparison study supported the conclusion that the Erytra Eflexis including the new automated serial dilution method, and single dilution and range titration techniques, yielded equivalent results to the comparative methods using FDA licenses reagents and instruments. In addition, an internal reproducibility and repeatability study was conducted. The study was done using three Erytra Eflexis in accordance to the following profile: 6 Samples x 3 Erytra Eflexis x 5 days x 2 runs (am/pm) x 2 replicates. The study demonstrated that the Erytra Eflexis consistently obtained the expected results and the reproducibility and repeatability of the results for these techniques was deemed demonstrated. In summary, the results of the in-house evaluation supported the conclusion that the Erytra Eflexis including the new automated serial dilution method, and single dilution and range titration techniques, can perform antibody titrations with its DG Gel 8 cards and Medion Grifols Diagnostics Reagent Red Blood Cells, safely and effectively. In addition, it is concluded that the Erytra Eflexis is substantially equivalent when compared to the results obtained using the same DG Gel 8 cards and Medion Grifols Diagnostics Reagent Red Blood Cells tested by the comparative methods. ### **Conclusions:** Diagnostic Grifols S.A. concludes, based on all the information submitted and discussed in this submission and in this summary that Erytra Eflexis, when used for the defined indications for use, performs as well as or better than the legally marketed predicate device Erytra Eflexis (BK230820). In addition, all the requirements for a product to be marketed in the United States have been demonstrated.