Erytra Eflexis
Device Facts
| Record ID | BK261329 |
|---|---|
| Device Name | Erytra Eflexis |
| Applicant | Diagnostic Grifols S.A. Barcelona, 08150, Spain |
| Product Code | KSZ · Hematology |
| Decision Date | May 21, 2026 |
| Decision | SESE |
| Regulation | 21 CFR 864.9175 |
| Device Class | Class 2 |
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.
Device Story
Erytra Eflexis is a fully automated immunohematology analyzer for clinical, donation, and transfusion laboratories. It processes human blood samples (plasma, serum, red blood cells) using DG Gel 8 cards. The system automates sample/reagent loading, incubation, centrifugation, and digital image analysis of gel cards. A high-resolution color CCD camera captures images of microtubes; software interprets results based on predefined rules. The device interfaces with LIS for data management. It reduces manual handling, contamination risk, and transcription errors while standardizing analytical interpretation. Operators load/unload samples and reagents; the system performs the analytical workflow. Output includes automated test results, which support clinical decision-making regarding blood compatibility and patient transfusion safety.
Clinical Evidence
Bench testing only. An in-house method comparison study compared the subject device (new camera) against the predicate device (current camera). A total of 1,529 samples (822 positive, including weak reactions; 707 negative) were analyzed across all immunohematology techniques. Results demonstrated equivalent performance between the two systems using FDA-licensed reagents.
Technological Characteristics
Automated immunohematology analyzer; uses DG Gel 8 cards; high-resolution color CCD camera for image acquisition; 3 independent incubators; 2 independent centrifuges; barcode scanning (various symbologies); LIS connectivity (unidirectional/bidirectional); software-based automated interpretation using predefined rules.
Indications for Use
Indicated for in vitro immunohematological testing of human blood, including ABO/Rh grouping, antigen typing, antibody screening/identification/titration, compatibility testing, and direct antiglobulin tests in clinical, donation, and transfusion laboratories.
Regulatory Classification
Identification
An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.
Predicate Devices
- Erytra Eflexis (BK251182)
Submission Summary (Full Text)
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Diagnostic Grifols, S.A.
510(k) Premarket Notification
Erytra Eflexis
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# **CH2.03 – 510(k) Summary**
# **Contact Details:**
Diagnostic Grifols S.A.
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: February 27th, 2026
# **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: BK251182
Device Class: II
Product Code: KSZ
Regulation Number: 21 CFR 864.9175
Clearance Letter June 17, 2025
# **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.
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Diagnostic Grifols, S.A.
510(k) Premarket Notification
Erytra Eflexis
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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.
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Diagnostic Grifols, S.A.
510(k) Premarket Notification
Erytra Eflexis
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# Comparison to Predicate Device:
| Parameter | Predicate Device Diagnostic Grifols S.A. Erytra Eflexis (BK251182) | 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 - 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. |
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Diagnostic Grifols, S.A.
510(k) Premarket Notification
Erytra Eflexis
5 - 4
| Parameter | Predicate Device Diagnostic Grifols S.A. Erytra Eflexis (BK251182) | 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 |
| **Reading system** | High-resolution color reading using a color CCD camera | New high-resolution color reading using a color CCD camera |
| **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 |
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Diagnostic Grifols, S.A.
510(k) Premarket Notification
Erytra Eflexis
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| Parameter | Predicate Device Diagnostic Grifols S.A. Erytra Eflexis (BK251182) | Subject Device Diagnostic Grifols S.A. Erytra Eflexis |
| --- | --- | --- |
| **Firmware/Software** | | |
| Interfaced with Laboratory Information System (LIS) | Yes - Unidirectional - Bidirectional | Yes - Unidirectional - Bidirectional |
| Capability to process STAT samples | Yes | Yes |
| QC procedures implemented | Yes | Yes |
| Automated results reading | Digital Image and Microtube Analysis incorporated in the Reader Module (DG-421) | Digital Image and Microtube Analysis incorporated in the Reader Module (DG-421) |
| Automated test interpretation | Yes. According to predefined rules stated in a definition file. | Yes. According to predefined rules stated in a definition file. |
The differences between the Erytra Eflexis and its predicate device, the Erytra Eflexis (BK251182), are related to the digital camera installed in the reading module of the instrument. The Erytra Eflexis incorporates a new compatible high-resolution color reading camera due to the obsolescence of the current one, in comparison to the predicate device. These differences do not raise new concerns of safety and effectiveness.
# Performance:
All new risks and associated hazard analysis related to the digital camera replacement have been performed and documented in accordance with ISO 14971 guidelines.
An in-house method comparison study was conducted with one Erytra Eflexis equipped with the current digital camera, and one Erytra Eflexis with the new digital camera. Both instruments performed automates testing using FDA-licensed Grifols Gel cards, 0.8% Reagent Red Blood Cells, and validated antisera reagents. The results obtained were then compared.
All immunohematology techniques covered in the device's intended use were evaluated in the method comparison study. A total of 822 positive samples, including weak reactions, and 707 negative samples were analyzed.
The results of the method comparison study supported the conclusion that the Erytra Eflexis, equipped with the new digital camera installed in the reading module of the instrument, yielded equivalent results to the comparative methods using FDA-licensed reagents.
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Diagnostic Grifols, S.A.
510(k) Premarket Notification
Erytra Eflexis
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In summary, the results of the in-house evaluation support the conclusion that the Erytra Eflexis, including the new camera, safely and effectively performs all immunohematology techniques using DG Gel 8 cards, Medion Grifols Diagnostics Reagent Red Blood Cells, and validated antisera reagents. Additionally, the evaluation demonstrated that the Erytra Eflexis is substantially equivalent when compared to results obtained using the same FDA-licensed reagents tested by the comparative method.
### **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 (BK251182). In addition, all the requirements for a product to be marketed in the United States have been demonstrated.
