Blood Bank Control System, Version 6.0
Device Facts
| Record ID | BK220790 |
|---|---|
| Device Name | Blood Bank Control System, Version 6.0 |
| Applicant | Blood Bank Computer Systems, Inc Bonney Lake, WA |
| Product Code | MMH · Hematology |
| Decision Date | Feb 17, 2023 |
| Decision | SESE |
| Regulation | 21 CFR 864.9165 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
Blood Bank Control System V6.0 is intended to be used by trained personnel to aid in the collection, manufacture and distribution of blood and blood components. The software is designed to identify eligible donors by the use of both user or donor administered history questionnaire functionality (Computer Assisted Self Interviews (CASI)) along with additional system logic to determine donor eligibility which includes testing as well as donor health screening. The system prevents the release of unsuitable blood and blood components for transfusion or further manufacturing by performing compatibility testing and aids in the manufacture, labeling and shipment of blood and blood products. The system supports the determination of compatibility status of product per patient for transfusion service operations.
Device Story
Blood Bank Control System V6.0 is a software-only device for blood establishment management. It processes donor history questionnaires (CASI), health screening data, and laboratory test results to determine donor eligibility and blood component suitability. The system manages manufacturing workflows, ensures compliance with time thresholds, generates ISBT labeling information, and performs compatibility testing for patient transfusion. Used in blood banks and transfusion services by trained personnel; the system provides automated logic to prevent the release of unsuitable blood products. It supports clinical decision-making by verifying testing completeness and determining crossmatch compatibility. Benefits include standardized donor screening, reduced risk of releasing unsuitable components, and streamlined blood product manufacturing and distribution.
Clinical Evidence
No clinical data. The device is a software-only system; performance was established through non-clinical bench testing, including Component Verification (CV) testing and System Level Testing (SLT) during alpha validation, followed by beta validation at two user facilities.
Technological Characteristics
Software-only device; Java Open JDK 14; Cloud-supplied or x64 PC/Server hardware; Ubuntu Linux or Cloud OS; TCP/IP communication protocols; API-based access. Design controls follow quality system regulations and FDA software guidance.
Indications for Use
Indicated for use by trained personnel in blood centers and transfusion services to manage donor eligibility, blood collection, component manufacturing, testing, labeling, shipment, and patient compatibility/transfusion services.
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).
Predicate Devices
- ABO Express, Version 2.0.0 (BK040056)
- ABO Wheels, Version 1.0.0 (BK140184)
- ABO QuickPass, Version 1.0.0 (BK140198)
