BK251188 · MAK-SYSTEM Group Ltd. London United Kingdom · MMH · Jun 11, 2025 · Hematology
Device Facts
Record ID
BK251188
Device Name
Patient Health Software (P.H.S) v11.0.0.0
Applicant
MAK-SYSTEM Group Ltd. London United Kingdom
Product Code
MMH · Hematology
Decision Date
Jun 11, 2025
Decision
SESE
Regulation
21 CFR 864.9165
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The eTraceLine / Patient Health Software (P.H.S) application is a modular, stand-alone blood transfusion, testing laboratory software dedicated to blood centers or community blood banks with transfusion services centers, hospitals transfusion services, reference labs, testing laboratories. eTraceLine/P.H.S is designed to aid and assist qualified and trained personnel to support the operations within their facilities. eTraceLine/P.H.S software supports single, centralized multi-sites and multi-organizations to be used centrally or in standalone. eTraceLine/P.H.S undertakes process controls for laboratory testing and transfusion service operations, manages, tracks and determines the suitability of the blood components and blood derivatives to reduce human error and contribute to patient safety. eTraceLine/P.H.S is intended to address all phases of laboratory activities and/or transfusion services operations at the laboratory department, transfusion service departments, hospital wards, and patient bedside. Functionality is provided for: - Patient identification at bedside and patient record management; - Supporting Patient immunohematology, virology, histocompatibility laboratory testing used for suitability and including reagent quality control; - Supporting HLA, HNA, and HPA laboratory testing; - Blood components preparation, release, and labelling (ISBT 128); - Blood components selection, testing, and issue of blood components under normal and emergency conditions, including serological crossmatch, electronic crossmatch, and remote crossmatch of blood components; - Tracking of blood components inventory, transformation, disposition, record transfusion details and related outcomes, and record-keeping of patient transfusion history for lookback; - Supporting therapeutic bleed orders. eTraceLine/P.H.S interfaces with Hospital Information Systems (HIS), laboratory testing instruments, BECS, Laboratory Information Systems (LIS), and blood storage devices.
Device Story
P.H.S is a modular, stand-alone software system for blood transfusion and laboratory testing management. It integrates with HIS, LIS, and laboratory instruments to manage patient records, immunohematology/virology/histocompatibility testing, blood component inventory, and transfusion tracking. Operated by trained personnel in clinical and laboratory settings, it supports bedside patient identification and electronic crossmatching. The system aids in reducing human error by automating process controls and tracking blood component suitability. It functions as a centralized or standalone platform, supporting multi-site operations via web-based architecture. Output includes test results, inventory status, and transfusion records, which assist clinicians in blood component selection and transfusion decision-making, ultimately enhancing patient safety.
Clinical Evidence
No clinical testing was performed. Evidence consists of software verification and validation, including Alpha and Beta (user site) testing to demonstrate performance under specified use conditions.
Technological Characteristics
Modular, stand-alone software using JAVA technology and 3-tier web architecture. Supports on-premise and cloud deployment. Interfaces with HIS, LIS, and laboratory instruments via standard network connections. Complies with ISBT 128 labeling standards. Software classification: Blood Establishment Computer Software (Enhanced Documentation).
Indications for Use
Indicated for use by qualified personnel in blood centers, community blood banks, hospital transfusion services, reference labs, and testing laboratories to manage laboratory testing, transfusion operations, blood component inventory, and patient transfusion history.
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
Patient Health Software (P.H.S) Version 2.0 (BK180232)
