← Product Code [MMH](/productcode/MMH) · BK220790 # Blood Bank Control System, Version 6.0 (BK220790) _Blood Bank Computer Systems, Inc Bonney Lake, WA · MMH · Feb 17, 2023 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/BK220790 ## Device Facts - **Applicant:** Blood Bank Computer Systems, Inc Bonney Lake, WA - **Product Code:** [MMH](/productcode/MMH.md) - **Decision Date:** Feb 17, 2023 - **Decision:** SESE - **Regulation:** 21 CFR 864.9165 - **Device Class:** Class 2 - **Review Panel:** Hematology - **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. ## Regulatory 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](/device/BK040056.md)) - ABO Wheels, Version 1.0.0 ([BK140184](/device/BK140184.md)) - ABO QuickPass, Version 1.0.0 ([BK140198](/device/BK140198.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} ## SECTION 5: 510(k) SUMMARY Establishment Registration Number: 3028885 Submitter: Blood Bank Computer Systems, Inc. (BBCS) 7206 Vandermark Rd. E Bonney Lake, WA 98391 253-333-0046 Contact: Amy Lloyd Corporate Resource Manager 253-333-0046 ext. 216 Submission prepared on November 11, 2022 Device: Proprietary Name: Blood Bank Control System, Version 6.0 Common Name: Blood Establishment Computer Software Classification: Class II, product code 81MMH Panel: Hematology Predicate: ABO Express, Version 2.0.0 (BK040056) ABO Wheels, Version 1.0.0 (BK140184) ABO QuickPass, Version 1.0.0 (BK140198) Device Description: Blood Bank Control System, V6.0 is a software only device manufactured by Blood Bank Computer Systems, Inc. (BBCS) that is a comprehensive software device that aids in the management of donor and transfusion services. The donor screening and blood collection services are used to establish the eligibility of the donor to donate a given procedure, and ensure that the donor screen and phlebotomy information is complete. The product manufacturing and testing services are used to determine the component was created in accordance with the acceptable time thresholds as well as determine information that would be used for ISBT labeling. Additionally, the device will determine which tests are required for release of the blood product and can be used to evaluate the completeness of the testing for release. The patient transfusion services can determine the suitability for crossmatch. Intended 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 Comparison Table: | Areas of Comparison | Blood Bank Control System, Version 6.0 | Predicate - ABO Express | Predicate – ABO Wheels | Predicate – ABO QuickPass | | --- | --- | --- | --- | --- | Blood Bank Computer Systems, Inc. Blood Bank Control System, V 6.0 Traditional 510(k) Submission Page 1 of 3 {1} | Hardware | Cloud Supplied Hardware or x64 PC/Server | IBM iSeries (AS/400) | PC | PC/Server | | --- | --- | --- | --- | --- | | Operating Systems | Cloud Supplied OS or UBUNTU Linux Server | IBM iSeries OS V6R1, V7R1, V7R3 | Windows10 and Server 2008 and 2012 | Windows Server 2012 | | Web Server | | | | Apache HTTP Web Server 8.0 | | Programming Language | Java Open JDK 14 | IBM RPG IV | Java 1.7 | Java 1.6 | | Database | None | IBM DB2 | MySQL 5.7 | None | | Communication Protocols | TCP/IP | TCP/IP | TCP/IP | TCP/IP | ### **Technological Characteristics:** As described in the table above, the proposed and predicate devices have similar technology in hardware, software, and peripheral usage, with the primary technological difference being Blood Bank Control System V6.0 is now accessed through application programming interfaces (APIs). While there are minor differences in principles of operation and technology characteristics between the proposed Blood Bank Control System V6.0 software device and the predicate devices, no new questions of safety or effectiveness were raised. The proposed Blood Bank Control System V6.0 software is substantially equivalent to the Predicate devices listed in terms of intended use, performance, technology characteristics, safety and effectiveness. ### **Performance Data:** The following performance data is provided in support of the substantial equivalence determination. ### **Non-Clinical Testing** Blood Bank Computer Systems' activities to assure adherence to design control include determining new risks introduced by the new functionality and analyzing those risks. Hazards are mitigated by identifying new requirements to reduce the hazard, providing appropriate warnings to the user or adding warning statements to the product labeling. Based on the identified hazards and requirements, test cases are written and executed to verify that the proper warnings or mitigations to the hazard have been implemented as stated by the requirements. The hazards, requirements and associated test cases are used to create the Traceability Analysis Matrix. Alpha validation was comprised of Component Verification (CV) Testing and System Level Testing (SLT). CV Testing was performed to ensure the system had met its intended use and implementation of all new requirements was successful and can be viewed in the Traceability Matrix. Any subsequent changes are assessed for necessary regression testing. The results of alpha validation demonstrated that safety critical functionality performed as expected. All failures were evaluated by a subject matter expert (SME) and either corrected or scheduled for future correction based upon risk. Beta validation was conducted at two user facilities, using the System Level Tests provided by BBCS (along with client specific configurations). The results of beta testing demonstrated that the software functioned as expected and met the required specifications. ### **Clinical Testing:** Clinical performance testing is not applicable for Blood Bank Control System, V6.0 as it is a software only device. ---Blood Bank Computer Systems, Inc. Blood Bank Control System, V 6.0 Traditional 510(k) Submission Page 2 of 3 {2} # **Conclusions:** Blood Bank Control System V6.0 was developed using the design controls incorporated in Blood Bank Computer Systems development processes, which are based on the quality system regulations. The *Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices dated May 11, 2005* and the *Guidance for Format for Traditional and Abbreviated 510(k)s dated September 13, 2019* were also both used. The non-clinical data supports the safety of the device and indicate that the software device will perform as well as the predicate device as demonstrated by the alpha and beta testing. The testing assessment verifies that the device performs as designed, per the functional requirements, when utilized within its intended use. ---Blood Bank Computer Systems, Inc. Blood Bank Control System, V 6.0 Traditional 510(k) Submission Page 3 of 3 --- **Source:** [https://fda.innolitics.com/device/BK220790](https://fda.innolitics.com/device/BK220790) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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