BK230811 · Diagnostic Grifols, S. A. Barcelona, Spain · MMH · Jul 24, 2023 · Hematology
Device Facts
Record ID
BK230811
Device Name
Blood Typing Manager, version 3.0
Applicant
Diagnostic Grifols, S. A. Barcelona, Spain
Product Code
MMH · Hematology
Decision Date
Jul 24, 2023
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System, and aids users in Antibody Identification procedure. Blood Typing Manager includes the following features: • Bidirectional connectivity with one or more LIS. • Provides the ability to centralize the management of Quality Control. • Allows user to load Grifols RRBCs antigenic tables and aids user in antibody identification results. • Allows user to view and validate results remotely prior to export to LIS. • Allows to create and print reports.
Device Story
Blood Typing Manager is stand-alone software for immunohematology data management; interfaces with Grifols Erytra, Erytra Eflexis, and DG Reader Net instruments and LIS. Software centralizes QC management, enables remote result validation, and assists in antibody identification via Grifols RRBC antigenic tables. Operators (trained lab technicians) use web-based interface to manage samples, validate results, and generate reports. Version 3.0.0 adds automated reflex/rerun ordering, multisite management, and manual order creation. Software aids clinical decision-making by streamlining data flow and providing decision support for antibody identification; benefits include improved workflow efficiency and standardized data management in transfusion settings.
Clinical Evidence
Bench testing only. Validation included regression analysis per ISO 14971, comparison study of the Ab ID module against manual AABB standard procedures, internal validation of automatic reflex test ordering (six rule configurations), and modular licensing verification. No clinical data provided.
Indicated for use by trained laboratory technicians as a transfusion data manager to interface/manage data between immunohematology instruments, Blood Establishment Computer Software, and Laboratory Information Systems, and to assist in antibody identification procedures. Rx only.
Regulatory Classification
Identification
Blood establishment computer software (BECS) is a device used in the manufacture of blood and blood components to assist in the prevention of disease in humans by identifying ineligible donors, by preventing the release of unsuitable blood and blood components for transfusion or for further manufacturing into products for human treatment or diagnosis, by performing compatibility testing between donor and recipient, or by performing positive identification of patients and blood components at the point of transfusion to prevent transfusion reactions. This generic type of device may include a BECS accessory, a device intended for use with BECS to augment the performance of the BECS or to expand or modify its indications for use.
Special Controls
*Classification.* Class II (special controls). The special controls for these devices are:(1) Software performance and functional requirements including detailed design specifications (
*e.g.,* algorithms or control characteristics, alarms, device limitations, and safety requirements).(2) Verification and validation testing and hazard analysis must be performed.
(3) Labeling must include:
(i) Software limitations;
(ii) Unresolved anomalies, annotated with an explanation of the impact on safety or effectiveness;
(iii) Revision history; and
(iv) Hardware and peripheral specifications.
(4) Traceability matrix must be performed.
(5) Performance testing to ensure the safety and effectiveness of the system must be performed, including when adding new functional requirements (
*e.g.,* electrical safety, electromagnetic compatibility, or wireless coexistence).
{0}
Diagnostic Grifols, S.A.
510(k) Premarket Notification
Blood Typing Manager
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 Number: 3002772505
Contact Person: Elvira Estapé
Regulatory Affairs Manager
Elvira.estape@grifols.com
Phone: +34-670922237
Date of Summary: April 28th, 2023
### Name of Device:
Trade Name: Blood Typing Manager
Regulation Number: 21 CFR 864.9165
Regulation Name: Blood establishment computer software and accessories
Regulatory Class: Class II
Product Code: MMH
### Identification of the Legally Marketed Device (Predicated Device):
Trade Name: Blood Typing Manager
510(k) Number: BK220744
Regulation Number: 21 CFR 864.9165
Regulation Name: Blood establishment computer software and accessories
Regulatory Class: Class II
Product Code: MMH
Clearance Letter October 4th, 2022
### Device Description:
Blood Typing Manager is a stand-alone software specifically designed to aid in interfacing and managing data among immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System, and to aid users in Antibody Identification procedure as part of the DG Gel System.
Blood Typing Manager can only be used with:
- Grifols Erytra® instruments,
- Grifols Erytra Eflexis® instruments,
- Grifols DG Reader Net instruments.
{1}
Diagnostic Grifols, S.A.
510(k) Premarket Notification
Blood Typing Manager
5 - 2
The main functions of the Blood Typing Manager software are:
- Connectivity with immunohematology instruments and Laboratory Information System
- Data results management
- Quality Control (QC) Management
- Load of Grifols RRBCs antigenic table and aid users in antibody identification results
- Results validation management
- Create and print reports
Blood Typing Manager can only work with tests validated by Grifols.
Blood Typing Manager is limited to skilled personnel who have received specific training on the use of this software. The Operator must also have Laboratory Technician-level training and knowledge of immunohematology. Blood Typing Manager is regarded as a “Rx only” product.
**Indications for Use:**
Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System, and aids users in Antibody Identification procedure.
Blood Typing Manager includes the following features:
- Bidirectional connectivity with one or more LIS.
- Provides the ability to centralize the management of Quality Control.
- Allows user to load Grifols RRBCs antigenic tables and aids user in antibody identification results.
- Allows user to view and validate results remotely prior to export to LIS.
- Allows to create and print reports.
{2}
Diagnostic Grifols, S.A.
510(k) Premarket Notification
Blood Typing Manager
5 - 3
# **Comparison to Predicative device:**
| | Predicate Device Blood Typing Manager (BK220744) | Subject Device Blood Typing Manager |
| --- | --- | --- |
| **Intended Use** | Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System. Blood Typing Manager includes the following features: • Bidirectional connectivity with one or more LIS. • Provides the ability to centralize the management of Quality Control. • Allows user to view and validate results remotely prior to export to LIS. • Allows to create and print reports. | Blood Typing Manager is a transfusion data manager software that aids in interfacing and managing data between immunohematology instruments, Blood Establishment Computer Software and Laboratory Information System, and aids users in Antibody Identification procedure. Blood Typing Manager includes the following features: • Bidirectional connectivity with one or more LIS. • Provides the ability to centralize the management of Quality Control. • Allows user to load Grifols RRBCs antigenic tables and aids user in antibody identification results. • Allows user to view and validate results remotely prior to export to LIS. • Allows to create and print reports. |
| **Classification** | II | II |
| **Regulation number** | 21 CFR 864.9165 | 21 CFR 864.9165 |
| **Regulation Name** | Blood establishment computer software and accessories | Blood establishment computer software and accessories |
| **Product Code** | MMH | MMH |
| **LISS Connectivity** | Bidirectional | Bidirectional |
| **Connectivity with multiple instruments** | Yes | Yes |
| **Management with multiple instruments** | Yes | Yes |
| **Accessibility** | Web-based interface | Web-based interface |
| **Secure Web access** | HTTPS | HTTPS |
| **Reports** | Create and print reports | Create and print reports |
{3}
Diagnostic Grifols, S.A.
510(k) Premarket Notification
Blood Typing Manager
5 - 4
| | Predicate Device Blood Typing Manager (BK220744) | Subject Device Blood Typing Manager |
| --- | --- | --- |
| **Database results** | Yes | Yes |
| **Results management** | View and Validate | View, edit and validate |
| **Automatic ordering of reflex and rerun tests** | No | Yes |
| **QC Management** | Yes | Yes |
| **Software version** | 2.0.0 | 3.0.0 |
### Main functionalities introduced with software version 3.0.0
The new software version 3.0.0 introduces new functionalities, several minor changes and resolution of defects derived from complaints. The main functionalities are described in Section 16 – Software. A detailed Revision History table including all changes from version 2.0.0 to 3.0.0 is included in Attachment 1.
The main functionalities introduced in software version 3.0.0 are:
- - Multisite management. Allow the possibility to assign access to a role in more than one laboratory.
- - Creation of manual orders by authorized users.
- - Authorized users will be able to request to execute again a profile (rerun) test.
- - Automatic rules to generate new orders (reflex) or repeat orders (rerun).
- - Allow the user to manage samples through Sample detail view.
- - Modify the interpretation results of non-validated orders.
- - Implementation of modular licensing system.
- - Load of Grifols RRBCs antigenic table and aid users in antibody identification results.
- - Cybersecurity improvements
### Performance:
All new risk and hazard analysis related to the new software version 3.0.0 have been performed and documented per ISO 14971 guidelines.
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.
{4}
Diagnostic Grifols, S.A.
510(k) Premarket Notification
Blood Typing Manager
5 - 5
Moreover, additional performance studies of some new functionalities were performed. A comparison study was performed to evaluate the performance of the Ab ID module of Blood Typing Manager compared with the antibody identification obtained manually, using AABB standard procedures.
Likewise, an internal study was performed to validate the correct performance of the automatic ordering of reflex tests of Blood Typing Manager. Six different reflex rules were created to cover different configurations before order creation and/or after receiving the results leading to a result action: creation of a new profile, creation of a rerun order or conversion of the trigger profile to another.
To finalize, an internal study was carried out to validate the modular licensing of Blood Typing Manager. Different licensing modules were tested to assess each feature under each license complied with the expected result.
In summary, the results of the validation and performance studies supported the conclusion that Blood Typing Manager software 3.0.0 with new main functionalities and improvements, meets the defined user needs and intended use when it is used in combination with Grifols immunohematology analyzers (Erytra, Erytra Eflexis and Reader Net) and connected to LIS.
#### **Conclusions:**
Diagnostic Grifols S.A. concludes, based on all information submitted and discussed in this submission and in this summary, that Blood Typing Manager with the new software version 3.0.0 and when used for the defined indications for use, performs as well as or better than the legally marketed predicate device Blood Typing Manager (BK220744) running under software version 2.0.0.
