Lookback Notification System version 2.0
Device Facts
| Record ID | BK241136 |
|---|---|
| Device Name | Lookback Notification System version 2.0 |
| Applicant | BioLife Plasma Services LP Bannockburn, IL |
| Product Code | MMH · Hematology |
| Decision Date | Feb 20, 2025 |
| Decision | SESE |
| Regulation | 21 CFR 864.9165 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The Lookback Notification System is intended to generate and maintain electronic lookback records and allows for the automated creation, distribution and updating of applicable consignee notifications to assist in effectively identifying and removing unsuitable units (Source Plasma), prior to manufacturing.
Device Story
LNS v2.0 is a cloud-based SaaS application hosted on Salesforce; manages electronic lookback records for Source Plasma. Inputs include post-donation information, manufacturing errors, positive test results, and brokered plasma data, entered manually or electronically via interfaces with APDS, DIS, and ODS databases. System automates creation, distribution, and updating of consignee notifications to facilitate removal of unsuitable plasma units before manufacturing. Used in office environments at corporate headquarters and plasma centers by Regulatory Affairs, Lookback, Center, and QA staff. Output consists of electronic records and notifications; assists healthcare/plasma facility personnel in identifying and quarantining unsuitable products, ensuring safety of plasma supply.
Clinical Evidence
No clinical data. Evidence consists of non-clinical bench testing, including software verification and validation per ANSI AAMI IEC 62304, cybersecurity risk assessment, and functional performance/usability testing. Testing confirmed system performance at standard and high capacities.
Technological Characteristics
Cloud-based SaaS application hosted on Salesforce. Interfaces with APDS, DIS, and ODS databases via Informatica/MuleSoft. Operates on company-managed workstations using supported OS and Google Chrome. Connectivity via wired network or Wi-Fi (min 3Mbps, <150ms latency). Complies with ANSI AAMI IEC 62304.
Indications for Use
Indicated for use by Regulatory Affairs, Lookback, Center, and QA personnel to manage lookback records and consignee notifications for Source Plasma units identified as unsuitable due to post-donation information, manufacturing errors, positive test results, or brokered plasma information.
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
- Lookback Notification System version 1.0 (BK150347)
