MMH · Blood Establishment Computer Software And Accessories
Hematology · 21 CFR 864.9165 · Class 2
Overview
| Product Code | MMH |
|---|---|
| Device Name | Blood Establishment Computer Software And Accessories |
| Regulation | 21 CFR 864.9165 |
| Device Class | Class 2 |
| Review Panel | Hematology |
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.
Classification Rationale
Class II (special controls). The special controls for these devices are:
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).
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| BK261333 | Blood Product Questionnaire Module (v2.0.0) | Buoy Software, LLC Austin, TX 78704 | Jun 8, 2026 | SESE |
| BK251256 | ImmuLINK (v3.3) | Immucor, Inc. Norcross, Georgia 30071 | Oct 24, 2025 | SESE |
| BK251241 | SafeTrace Tx® Software 5.0.0 | Haemonetics Corporation Boston, MA 02110 | Sep 10, 2025 | SESE |
| BK251188 | Patient Health Software (P.H.S) v11.0.0.0 | MAK-SYSTEM Group Ltd. London United Kingdom | Jun 11, 2025 | SESE |
| BK241136 | Lookback Notification System version 2.0 | BioLife Plasma Services LP Bannockburn, IL | Feb 20, 2025 | SESE |
| BK241061 | bexWISE API v1.0 | IT Synergistics, LLC Flowood, MS | Oct 25, 2024 | SESE |
| BK241081 | Blood Product Administration Module (BPAM 4-2023) | Epic Systems Corporation Verona, WI | Aug 21, 2024 | SESE |
| BK241080 | ImmuLINK (v3.2) | Immucor, Inc. Norcross, GA | Aug 6, 2024 | SESE |
| BK241069 | Blood Bank Information Management System (BBIMS) v3.01 | Carter BloodCare Bedford, TX | Jul 9, 2024 | SESE |
| BK241062 | BloodTrack Software 4.16.0 | Haemonetics Corporation Boston, MA | Jun 21, 2024 | SESE |
| BK230958 | HemDonER 1.0.1 | eDonorSoft, LLC Sugarland, TX | May 31, 2024 | SESE |
| BK230814 | SmartDMS | Life Plasma, Inc. Reading, PA | Apr 16, 2024 | SESE |
| BK231036 | NexLynk DMS® Donor Management System 4.10.0 | Haemonetics Corporation Boston, MA | Mar 15, 2024 | SESE |
| BK231004 | Blood Product Questionnaire Module | Buoy Software, LLC Westport, CT | Nov 16, 2023 | SESE |
| BK230986 | ePROGESA v5.0.3 | MAK-SYSTEM Group Ltd. London United Kingdom | Nov 3, 2023 | SESE |
| BK230811 | Blood Typing Manager, version 3.0 | Diagnostic Grifols, S. A. Barcelona, Spain | Jul 24, 2023 | SESE |
| BK230826 | WellSky® Transfusion 2022 R3 | WellSky Corporation Overland Park, KS | Jul 19, 2023 | SESE |
| BK220791 | e-Delphyn Donor | GPI USA, Inc. Houston, TX | Jun 26, 2023 | SESE |
| BK230806 | ImmuLINK (v3.0) | Immucor, Inc. Norcross, GA | Apr 25, 2023 | SESE |
| BK220790 | Blood Bank Control System, Version 6.0 | Blood Bank Computer Systems, Inc Bonney Lake, WA | Feb 17, 2023 | SESE |
Top Applicants
- Haemonetics Corporation Boston, MA — 2 clearances
- Immucor, Inc. Norcross, GA — 2 clearances
- MAK-SYSTEM Group Ltd. London United Kingdom — 2 clearances
- BioLife Plasma Services LP Bannockburn, IL — 1 clearance
- Blood Bank Computer Systems, Inc Bonney Lake, WA — 1 clearance
