(117 days)
The Dimension® RxL Max® Clinical Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System is a discrete random access, microprocessorcontrolled, integrated instrument/chemistry system that measures a variety of analytes, including enzyme activities in body fluids. The system menu will include assays, such as Calcium, along with other various assays that may be adaptable to the analyzer depending on the reagent used.
Calcium is intended to quantitatively measure Calcium in human serum or plasma. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany.
The Dimension® RxL Max® Chemistry System is a continuous operation chemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens and is a family member of the Dimension® XL Clinical Chemistry System (traditional 510(k) filed in 1994 K944093). The Dimension® RxL Max® Chemistry System has also been cleared with StreamLab Analytical WorkCell and Sample Transfer Module (K043546)
The ADVIA® Modular Automation System (AMAS) is a laboratory automation system (LAS) designed to automate sample handling and processing in the clinical laboratory. AMAS is available as two products ADVIA® LabCell® and ADVIA® WorkCell. These LAS systems are made up of the same components and are controlled by common software. The systems differ in their expansion capabilities:
ADVIA® WorkCell is an ADVIA® Automation solution that is limited to three fixed configurations supporting up to a total of five interface stations.
ADVIA® LabCell® is customizable ADVIA® Automation solution that is configurable with up to 16 interface stations.
Dimension® RxL Max® Chemistry System (Dimension) with Sample Transfer Module and the ADVIA® Modular Automation System combines the features of both the analyzer and the laboratory automation system.
The ADVIA® Modular Automation System (AMAS) routes samples to the Dimension analyzer based on test request information received from the Laboratory Information System (LIS) and the test map established for the Dimension analyzer. AMAS and Dimension communicate sample and analyzer status via Dimension's Laboratory Automation System (LAS) interface. Via its Laboratory Information System (LIS) interface, the Dimension analyzer interfaces separately with the hospital's LIS to receive its test instructions (test requests) and to report results for each sample. Dimension's test instructions and test results for each sample are not processed through the AMAS.
AMAS performs the following pre and post-analytical functions.
- Sample bar code identification (previously performed by the Dimension) .
- Sample transport and tracking (pre-Analytical) .
- Sample centrifugation (optional functionality) .
- Sample de-capping (optional functionality) .
- Sample transport and tracking (post-Analytical) .
The Dimension continues to perform the following functions, when connected to AMAS.
- All functions except reading the sample tube bar code. When Dimension is . connected to AMAS, samples can be loaded directly onto Dimension and/or loaded onto AMAS and routed to Dimension. For samples loaded onto the AMAS, which reads the sample tube bar code (sample identification) and passes it electronically to Dimension via the LAS interface.
The document describes the Dimension® RxL Max® Chemistry System with Sample Transfer Module and the ADVIA® Modular Automation System and its substantial equivalence to a predicate device for measuring Calcium in human serum or plasma.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state pre-defined acceptance criteria in terms of specific performance thresholds for metrics like correlation coefficient, slope, intercept, or bias. Instead, it presents results of a method comparison study for the Calcium assay and aims to demonstrate substantial equivalence to the predicate device.
The study's implicit "acceptance criteria" appear to be that the performance metrics of the proposed device are within an acceptable range compared to the predicate device, as concluded by the statement of substantial equivalence.
| Metric | Reported Device Performance (Calcium assay) | Implicit Acceptance/Comparison to Predicate |
|---|---|---|
| n | 98 | Sample size for method comparison |
| r (correlation coefficient) | 0.989 | Very strong correlation between methods |
| Slope | 1.05 | Close to 1.0, indicating good agreement |
| Intercept | -0.4 | Close to 0, indicating minimal constant bias |
| Syx | 0.3 | Measure of scatter around the regression line |
| 95% CI Slope | 1.02 to 1.08 | Range includes 1.0, supporting agreement |
| 95% CI Intercept | -3.5 to 2.7 | Range includes 0, supporting agreement |
| % Mean Bias | -0.1 | Very low, indicating minimal systematic difference |
Conclusion from document: "The proposed Dimension® RxL MAX® with ADVIA® Modular Automation System and the predicate Dimension® RxL Max® (K043546) are substantially equivalent in design, modes of operation, assay performance and intended use."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 98 samples were used for the method comparison study ("n" = 98 in the table).
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. It is generally assumed for such 510(k) submissions that data is generated from studies conducted in a controlled environment, likely a clinical laboratory, but specific details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This type of device (a chemistry analyzer for Calcium levels) typically uses quantitative chemical analysis as its "ground truth" rather than expert interpretation of images or clinical assessments. The reference method for comparison (the predicate device) serves as the standard against which the proposed device is evaluated. Therefore, no human experts are explicitly mentioned for establishing ground truth in the context of diagnostic interpretation.
4. Adjudication Method for the Test Set
Not applicable. The study involved a direct comparison of quantitative measurements from two analytical instruments (proposed device vs. predicate device) on the same samples. There is no mention of human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where multiple human readers assess cases, and AI assistance is evaluated for its impact on their performance. The described study is a method comparison for a quantitative chemistry analyzer.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the method comparison presented is a standalone performance study of the device (analyzer) itself. The results (n, r, Slope, Intercept, Syx, % Mean Bias) directly reflect the analytical performance of the Dimension® RxL MAX® with AMAS for Calcium measurement when compared to the predicate Dimension® RxL MAX® without AMAS functionality. There is no human-in-the-loop component for this performance evaluation; it's a direct comparison of the instrument's quantitative output.
7. The Type of Ground Truth Used
The "ground truth" for the test set was established by the results obtained from the legally marketed predicate device, the Dimension® RxL Max® (K043546). This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the performance of the new device is compared directly to an already cleared device for the equivalent measurement. The study used a "split-sample method comparison," meaning the same clinical samples were analyzed on both the predicate and proposed devices.
8. The Sample Size for the Training Set
The document does not provide any information regarding a "training set" or its sample size. This is a common omission in 510(k) summaries for in vitro diagnostic (IVD) devices like chemistry analyzers. These devices are typically developed, calibrated, and validated through internal processes by the manufacturer, rather than through a public "training set" as understood in machine learning contexts. The presented method comparison study (n=98) serves as the "test set" for regulatory clearance purposes.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or described in the provided summary, there is no information on how its ground truth would have been established. It's likely that development and internal validation used various known standards, controls, and patient samples, but these are not disclosed as part of the 510(k) summary focused on the substantial equivalence study.
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.