(119 days)
The ACCELERATOR APS (Automated Processing Systems) is a modular system designed to automate pre-analytical processing, sample handling, and processing in the clinical laboratory. The system consolidates multiple analytical instruments into a unified workstation by employing a common sample processing capability.
The ARCHITECT c8000 System is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The ARCHITECT c8000 System also has a solid state Ion-Selective Electrode module, utilizing potentiometry, for electrolyte determinations for Sodium, Potassium and Chloride.
Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment diseases involving electrolyte imbalance.
The ACCELERATOR APS (Automated Processing Systems) is a modular system designed to automate pre-analytical sample processing, sample handling, and processing in the clinical laboratory. The system consolidates multiple analytical instruments into a unified workstation by employing a common sample processing capability. The workcell software provides for workload management, sample order management, and instrument operational status monitoring. This is accomplished through communication connections between the workcell, analyzers, and LIS (laboratory information systems) or middleware.
The ACCELERATOR APS performs the following pre and post-analytical functions.
- Sample bar code identification (previously performed by the analyzer)
- Sample transport and tracking
- Sample centrifugation (Optional functionality)
- Sample de-capping (Optional functionality)
- Tube sealing (Optional functionality)
- Sample Storage and Retrieval (Optional functionality)
The ARCHITECT Family of Instruments test instructions and test results for each sample are not processed through the ACCELERATOR APS.
The following analyzers have been validated for use with the ACCELERATOR APS.
- ARCHITECT cSystems (c8000 and c16000)
- ARCHITECT i2000
- ARCHITECT i2000sr
Here's a breakdown of the acceptance criteria and study details for the ACCELERATOR APS, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Representative Method | Minimum Number of Specimens | Correlation Coefficient (Acceptance) | Correlation Coefficient (Reported) | Slope (Acceptance) | Slope (Reported) | Mean % Bias (Acceptance) | Mean % Bias (Reported) |
|---|---|---|---|---|---|---|---|
| Sodium | 57 | ≥ 0.975 | 0.9941 | 0.95-1.05 | 0.99 | ≤ 3% @ 120-150 mmol/L | 0.03 |
| Potassium | 57 | ≥ 0.975 | 0.9999 | 0.95-1.05 | 0.99 | ≤ 3% @ 3.0-6.0 mmol/L | -0.09 |
| Chloride | 58 | ≥ 0.975 | 0.9986 | 0.95-1.05 | 0.98 | ≤ 3% @ 90-120 mmol/L | -0.30 |
2. Sample Size and Data Provenance
- Sample Size for Test Set:
- Sodium: 58 specimens
- Potassium: 58 specimens
- Chloride: 58 specimens
- Data Provenance: Not explicitly stated. The document refers to a "method correlation comparison study" using "specimens," implying de-identified clinical samples, but does not specify their origin (e.g., country) or whether the data was retrospective or prospective.
3. Number of Experts and Qualifications for Ground Truth
- This information is not applicable to this particular study. The study focuses on the analytical performance comparison between two instrument configurations (standalone vs. integrated with ACCELERATOR APS) for measuring specific analytes (Sodium, Potassium, Chloride). The "ground truth" in this context is the measurement obtained from the predicate device (standalone ARCHITECT c8000), not an expert interpretation of images or clinical outcomes. Therefore, no experts were used to establish ground truth in the traditional sense of diagnostic accuracy studies.
4. Adjudication Method for the Test Set
- Not applicable. As the study is an analytical method comparison, there is no need for adjudication as one would find in studies involving human interpretation or subjective assessments. The comparison is objective, based on quantitative measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was not an MRMC study. The ACCELERATOR APS is an automated pre-analytical and sample handling system, not a diagnostic imaging or AI-assisted diagnostic tool that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
- Yes, in essence. The entire study is a standalone performance comparison of the device itself (ACCELERATOR APS integrated with ARCHITECT c8000) against a predicate device (standalone ARCHITECT c8000). The comparison evaluates the analytical performance of the integrated system in isolation, without direct human intervention in the measurement process (beyond initial sample loading and system operation). The performance metrics (correlation, slope, bias) assess the algorithm's (or system's) ability to produce results comparable to the predicate.
7. Type of Ground Truth Used
- Predicate Device Measurement: The "ground truth" for comparison was the analytical measurement of Sodium, Potassium, and Chloride obtained from the standalone ARCHITECT c8000 analyzer. This served as the reference against which the ACCELERATOR APS integrated system's results were compared to demonstrate substantial equivalence.
8. Sample Size for the Training Set
- Not applicable. The ACCELERATOR APS is a hardware and software system for automating laboratory processes, not a machine learning model that requires a "training set" in the conventional sense. The system's functionality is based on predefined automation sequences and analytical principles, not learned patterns from data.
9. How Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, this question is not relevant.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.