(86 days)
The basic Power Processor is an automated sample handling system which processes sample tubes from the pre-centrifugation, pre-sorting step to presentation of centrifuged and decapped samples into Generic or Personality Racks for specific instruments. The Power Processor can be configured with optional software and hardware to allow processing of sample tubes on Generic Connection Instruments. The Power Processor performs all pre-analytical sample tube preparation, and then sorts the sample tubes directly to Generic Connection Modules where the samples are pipetted by the Generic Connection instrument for testing. After the samples are pipetted, the tubes can route to other instruments for additional testing or to Outlet Racks.
The UniCel DxI 600/800 Access Immunoassay System(s) with laboratory automation connection is a microcomputer-controlled, random and continuous access analyzer that includes an external computer. This computer stores the system user interface (U) software and allows the operator to interface with and direct the instrument software. The UniCel DxI 600/800 System(s) uses enzyme immunoassays (utilizing paramagnetic particle solid phase and chemiluminescent detection) for determination of various analytes, such as Vitamin B12, Ferritin, Folate and hTSH along with other various enzyme immunoassays assays that may be adaptable to the analyzer depending on the reagent used to induce the enzyme immunoassay reaction. The UniCel DxI 600/800 System(s) is an in vitro diagnostic device for use in the clinical laboratory.
The Access Ferritin assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of ferritin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism.
The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) and red blood cells using the Access Immunoassay Systems. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia.
The Access HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Access Vitamin B12 assay is a paramagnetic particle, chemiluminescent assay for the quantitative determination of vitamin B12 in human serum and plasma (heparin) using Access Immunoassay Systems. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
The Power Processor is a scalable laboratory automation system (LAS) designed to streamline pre-analytical processes in the clinical laboratory. A basic Power Processor System is comprised of a Line Control Computer, Preplink™ Computer, Inlet Module, Hematology Module, Centrifugation Module, Decapper Module, and Outlet Module, In the basic configuration, patient sample tubes are loaded onto the Power Processor system to be sorted to a Hematology Module, or to be centrifuged, decapped, and sorted to Personality Racks for further processing on other instruments. Additional modules may be added for aliquot capability, sample capping, and refrigerated storage.
The Power Processor is an open architecture system that can connect to a variety of clinical analyzers, including Beckman Coulter and third party systems. Connection modules are extensions of the Power Processor track system that link with an analyzer's existing LAS interface. Connection modules support one of two types of sample transfer methods: onboard or outboard sampling.
Onboard sampling physically transfers the sample tube/rack from the automation track to the analyzer's sample load and identification area. This method is used to establish connection with Beckman Coulter's Synchron LX® and UniCel® DxC Systems and some third party analyzers.
With outboard sampling, the connection unit performs the sample bar code read function, presents the sample ID to the connected analyzer, and then signals for direct sampling of the open tube by the connected instrument at an aspiration point on the automation track. The Power Processor Generic Connection Module is specifically designed to support the outboard sampling method based on point-in-space pipetting technology aligned with the CSLI guidelines.
The provided text describes a 510(k) submission for a software upgrade to a laboratory automation system, the "Power Processor Sample Processing System with Generic Connection Module to Software Version 5.0." This submission focuses on demonstrating substantial equivalence to a predicate device (the same system with Software Version 3.5). As such, the information provided is not typical for a study demonstrating performance against specific quantitative diagnostic or clinical acceptance criteria as might be seen for a new diagnostic device.
Instead, the "acceptance criteria" here are implicitly related to the successful validation of the software upgrade and its functionality, ensuring it performs as intended and maintains the safety and effectiveness of the existing device. The "study" that proves these criteria are met is the internal validation testing of the software.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Increased Generic Connection Capacity: Support up to 12 generic connections (from 4). | Software Version 5.0 allows the system to connect up to 12 generic connections. |
| Increased Primary Sample ID Length: Support 13 characters for primary ID + 2 secondary. | Software Version 5.0 provides an option to increase the primary sample ID to 13 characters, plus 2 characters for the secondary sample ID. |
| Increased Stockyard Capacity: Support up to three 3K or three 5K tube stockyards. | Software Version 5.0 provides an option to connect up to three 3K or three 5K tube stockyards. |
| Improved Load Balancing: Option for load balancing by tubes per rack instead of round robin. | Software Version 5.0 provides an option for load balancing number of tubes per rack instead of round robin. |
| Data Migration Utility: Provision for upgrading from V3.5/V3.6 to V5.0. | Software Version 5.0 provides Data Migration Utility (DMU) for V3.5/V3.6 to V5.0. |
| Unassigned Test Tube Routing: Option to route primary tubes with no assigned tests to stockyard. | Software Version 5.0 provides an option to route a primary tube with no assigned tests in its test order to the stockyard. |
| Data Backup/Restore: Option to backup/restore data files on USB drives. | Software Version 5.0 provides an option to backup/restore the data files on USB drives. |
| Overall Software Functionality and Equivalence: All software design, development, and verification activities completed and passed, supporting equivalency to V3.5. | "Performance data from validation testing shows that all software design, development and verification activities have been completed and passed, and supports equivalency of Power Processor V5.0 to Power Processor V3.5." |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly mentions "validation testing" but does not provide details on the sample size for this testing (e.g., number of test cases, tubes processed, or specific scenarios simulated).
The data provenance is internal to Beckman Coulter, Inc. as it refers to their internal "software design, development and verification activities." The data would be prospective in the sense that the testing was conducted specifically for this software validation. There is no mention of country of origin for the data itself, but the manufacturer is based in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This type of information (experts, qualifications) is typically relevant for diagnostic devices where human interpretation or clinical judgment is part of establishing ground truth. For a software upgrade to an automation system, the "ground truth" is defined by the functional specifications and expected behavior of the software. Therefore, no external experts or clinicians are mentioned as being involved in establishing ground truth in the context of this software validation. The "ground truth" for the software's performance is its adherence to its design specifications, verified by the internal testing team.
4. Adjudication Method for the Test Set:
Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers or experts when establishing a ground truth for diagnostic accuracy. Since this is a software upgrade to an automation system, and not a diagnostic device involving human interpretation of results, no adjudication method would be relevant or mentioned. The "adjudication" in a software validation context would be the resolution of any bugs or deviations from specifications identified during testing by the software development and quality assurance teams.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. MRMC studies are used to assess the impact of a device (often AI-assisted) on human reader performance, typically in diagnostic imaging or similar fields. This submission is for a software upgrade to a laboratory automation system, which does not involve human readers in interpreting clinical data to make a diagnosis in the same way. The software's role is to streamline pre-analytical processes, not to assist humans in diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device itself (Power Processor Sample Processing System with Generic Connection Module V5.0) operates as a standalone automation system that processes samples. The "performance data from validation testing" is essentially a standalone performance assessment of the software and system. There is no mention of human-in-the-loop performance measurement as part of this validation, confirming that the assessment was of the system's inherent functional capabilities.
7. The Type of Ground Truth Used:
The ground truth used for this software validation is based on functional specifications and expected system behavior. The "performance data from validation testing shows that all software design, development and verification activities have been completed and passed" implies that the software's outputs and actions were compared against its predefined and expected operational characteristics. It is not expert consensus, pathology, or outcomes data, as these are related to clinical diagnostic accuracy rather than automation system functionality.
8. The Sample Size for the Training Set:
This document describes a software upgrade and its validation, not the development of a predictive algorithm or AI model that typically requires a "training set." Therefore, no information on a training set sample size is provided or relevant in this context.
9. How the Ground Truth for the Training Set was Established:
As explained in point 8, there is no mention or indication of a "training set" for an algorithm. The software's functionality is developed based on engineering requirements and validated against those requirements.
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.