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).
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SafeTrace Tx 5.0.0
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HAEMONETICS®
# 510(k) Summary
Date
June 25, 2025
Submitter
Haemonetics Corporation
125 Summer Street
Boston, MA 02110
Contact
Samantha Schroeder
Senior Regulatory Affairs Specialist
Phone: 913-548-2288
Email: SSchroeder@Haemonetics.com
Device Information
| *TRADE Name:* | SafeTrace Tx® Software |
| --- | --- |
| *Common Name:* | Blood Establishment Computer Software |
| *Classification Name:* | Blood Establishment Computer Software and Accessories |
| *Regulation Number:* | 21 CFR 864.9165 |
| *Review Panel:* | Hematology |
| *Product Code:* | MMH |
| *Device Class:* | 2 |
Legally Marketed Predicate Device
| Predicate # | Predicate Trade Name | Product Code |
| --- | --- | --- |
| BK180209 | SafeTrace Tx 4.0.0 | MMH |
Device Description Summary
The SafeTrace Tx® software is a web-based electronic information system designed to support single, multi-site or centralized transfusion service operations in determining the suitability of blood and blood components for release. The software application maintains a complete test and transfusion history for a patient and enables end-to-end management and traceability of blood and blood components from receipt through final disposition.
Intended 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.
Haemonetics Corporation | 125 Summer Street | Boston, MA 02110
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SafeTrace Tx 5.0.0
Attachment 34
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# HAEMONETICS®
## Indications for Use
The SafeTrace Tx ® software is a web-based electronic information system that;
- 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.
## Indications for Use Comparison
The Indications for Use for the SafeTrace Tx Software have been clarified to describe only the medical functionality and to remove non-medical functionality, which were not critical to the safety and effectiveness of the software device when used as labeled. Indications related to medical functionality are the same for the SafeTrace Tx 5.0.0 and the predicate, SafeTrace Tx 4.0.0 (BK180209).
## Technological Comparison
There is no change to the underlying technology, or principle of operation from the predicate SafeTrace Tx 4.0.0 (BK180209). The device functions with the same intended use to support single, multi-site or centralized transfusion service operations in determining the suitability of blood and blood components for release. Through the discussion on substantial equivalence, the risk management documentation, and the testing provided, it is concluded that the changes associated with SafeTrace Tx 5.0.0 do not change the risk-benefit profile of the SafeTrace Tx Software.
## Non-Clinical and/or Clinical Tests
The non-clinical testing performed to support this premarket submission was performed in accordance with the FDA Guidance, General Principles of Software Validation (2002). The software testing consisted of thorough verification and validation testing to ensure the subject device is as safe, as effective, and performed as well as or better than the predicate device.
No clinical testing was performed in support of this premarket submission for the SafeTrace Tx Software.
## Summary & Conclusions
The non-clinical testing and comparison to the predicate device show the subject SafeTrace Tx 5.0.0 software to be substantially equivalent to the predicate device and that there is no impact to the safety and effectiveness of the device.
Results from the non-clinical testing demonstrate that the SafeTrace Tx 5.0.0 software is as safe and effective, and it performs as well as its proposed predicate device.
In conclusion, the SafeTrace Tx 5.0.0 software is substantially equivalent to the predicate device in terms of functionality, performance, technological characteristics, and Indications for Use, including for safety and effectiveness.
Haemonetics Corporation | 125 Summer Street | Boston, MA 02110
