(169 days)
The ADVIA Centaur with StreamLAB® Analytical Workcell is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include assays based on chemiluminescent technology, such as Thyroxine, along with other various chemiluminescent assays that may be adaptable to the analyzer depending on the reagent used to induce the chemiluminescent reaction.
The ADVIA Centaur T4 assay is for in vitro diagnostic use in the quantitative determination of thyroxine (T4) in serum on the ADVIA Centaur and ADVIA Centaur XP systems. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
The ADVIA Centaur® is a continuous operation, immunochemistry analyzer designed to perform in vitro diagnostic testing on clinical specimens.
The StreamLAB® Analytical Workcell is a laboratory automation system (LAS) designed to automate sample handling and processing in the clinical laboratory.
The ADVIA Centaur® with StreamLAB® Analytical Workcell combines the features of both the analyzer and the laboratory automation system.
The StreamLAB routes samples to the Centaur analyzer based on test request information it (StreamLAB) receives from the Laboratory Information System (LIS) and the test map established for the Centaur analyzer. StreamLAB and Centaur communicate sample and analyzer status via Centaur's Laboratory Automation System (LAS) interface. Via its LIS interface, the Centaur analyzer interfaces separately with the hospital's LIS to receive its test instructions (test requests) and to report results for each sample. Centaur's test instructions and test results for each sample are not processed through the StreamLAB.
The StreamLAB performs the following pre and post-analytical functions.
- Sample bar code identification (previously performed by the Centaur) .
- . Sample transport and tracking
- . Sample centrifugation (optional functionality)
- . Sample de-capping (optional functionality)
- Sample transport and tracking
- Tube sealing (optional functionality) .
The Centaur continues to perform the following functions, when connected to the StreamLAB.
- . All functions except reading the sample tube bar code. When Centaur is connected to StreamLAB, samples can be loaded directly onto Centaur and/or loaded onto StreamLAB and routed to Centaur. For samples loaded onto StreamLAB, StreamLAB reads the sample tube bar code (sample identification) and passes it electronically to Centaur via the LAS interface to Centaur.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study proving the device meets them:
Device: ADVIA Centaur® with StreamLAB® Analytical Workcell
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds as typically seen in modern submissions. Instead, it relies on a "method comparison" study to demonstrate substantial equivalence to a predicate device. The performance is reported in terms of linear regression parameters (slope, intercept, correlation coefficient) comparing the new device to the predicate.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (ADVIA Centaur® T4 Assay) |
|---|---|---|
| Linear Regression - Slope | Implicit: Close to 1.0 (indicating agreement between devices) | 1.01 |
| Linear Regression - Intercept | Implicit: Close to 0.0 (indicating no systematic bias) | -0.03 |
| Linear Regression - Correlation Coefficient (r) | Implicit: High, close to 1.0 (indicating strong linear relationship) | 0.999 |
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2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the method comparison study. It only mentions that "Split-sample method comparison studies were conducted using the ADVIA Centaur® T4 Assay."
- Sample Size: Not explicitly stated.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective in the sense that samples were collected and then tested on both systems, but there is no indication of whether these were new prospective samples collected for the study or previously stored retrospective samples. Given the context of a 510(k) for an in vitro diagnostic, samples would typically be clinical specimens.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable to this submission. The device is an automated immunoassay analyzer for quantitative determination of Thyroxine (T4). The "ground truth" for such devices is established by comparing its measurements against a recognized reference method or a predicate device, as done in this "method comparison" study. There is no subjective interpretation by human experts involved in establishing the T4 values for the test set.
4. Adjudication Method for the Test Set
This section is not applicable to this submission. The "ground truth" (comparison values from the predicate device) for quantitative diagnostic devices like this is based on the analytical measurement of the predicate device, not on expert adjudication of subjective findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done.
This type of study is relevant for diagnostic devices where human readers interpret images or data, and AI assistance can potentially improve their performance. The ADVIA Centaur with StreamLAB Analytical Workcell is an automated analyzer that performs quantitative immunoassays, with no human interpretation component in the diagnostic process itself.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a form of standalone performance was demonstrated.
The "Method Comparison" study demonstrates the performance of the proposed device (ADVIA Centaur with StreamLAB) in performing T4 assays independently, against the predicate device (ADVIA Centaur) which also operates as an automated system. This comparison evaluates the algorithm's performance in generating the quantitative T4 results. There is no human-in-the-loop component in the T4 measurement process itself.
7. The Type of Ground Truth Used
The "ground truth" in this context is the measurements obtained from the predicate device, the ADVIA Centaur® (K041133) using the ADVIA Centaur® T4 Assay. The study compares the new device's quantitative T4 results directly to the established, legally marketed predicate device on the same split samples.
8. The Sample Size for the Training Set
The document does not provide information regarding a training set sample size. For in vitro diagnostic (IVD) devices like this, particularly for a 510(k) submission showing substantial equivalence, the focus is typically on analytical and clinical performance studies (like method comparison) rather than an AI/ML model's training phase. While the internal development of assays and instruments involves extensive calibration and validation, this is distinct from "training data" as understood in AI/ML contexts where a model learns from data.
9. How the Ground Truth for the Training Set Was Established
As noted above, the document does not provide information about a specific "training set" or how its ground truth was established, as the submission focuses on demonstrating equivalence through direct method comparison rather than an AI/ML model's training process.
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.