SafeTrace Tx® Software 5.0.0
Device Facts
| Record ID | BK251241 |
|---|---|
| Device Name | SafeTrace Tx® Software 5.0.0 |
| Applicant | Haemonetics Corporation Boston, MA 02110 |
| Product Code | MMH · Hematology |
| Decision Date | Sep 10, 2025 |
| Decision | SESE |
| Regulation | 21 CFR 864.9165 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The SafeTrace Tx® software is a web-based electronic information system intended to manage transfusion service operations and assist in the determination of the suitability of released products. The software application maintains a complete test and transfusion history for a patient and manages and tracks blood and blood components from receipt to final disposition. The SafeTrace Tx software provides the following functionality: - Performs electronic crossmatching and safety and compatibility checks between patient and product. - Provides information to assist in the determination of the suitability and compatibility of blood and blood components with potential recipients. - Helps prevent the release of unsuitable or incorrect blood and blood components for potential recipients and for further manufacturing.
Device Story
SafeTrace Tx 5.0.0 is a web-based electronic information system for transfusion services; manages blood/blood component lifecycle from receipt to final disposition. Inputs include patient test history, transfusion history, and blood component data. Software performs electronic crossmatching and safety/compatibility checks; assists clinicians in determining product suitability; prevents release of incorrect or unsuitable components. Used in single, multi-site, or centralized transfusion service environments. Output provides decision support for blood release; enhances patient safety by reducing risk of transfusion errors.
Clinical Evidence
No clinical data. Non-clinical testing performed per FDA Guidance, General Principles of Software Validation (2002). Verification and validation testing confirmed subject device is as safe and effective as the predicate.
Technological Characteristics
Web-based electronic information system; software-only device. Functions as a blood establishment computer system for data management, crossmatching, and traceability. No changes to underlying technology or principle of operation from predicate.
Indications for Use
Indicated for transfusion service operations to perform electronic crossmatching, safety and compatibility checks between patients and blood products, and to assist in determining suitability of blood components for recipients and further manufacturing.
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
- SafeTrace Tx 4.0.0 (BK180209)
