(92 days)
The intended use of the ACS:Centaur system is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assays analysis on clinical specimens using the ACS ilmmunoassays. The system menu will include endocrine, anemia, reproductive, cardiac, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.
The ACS:Centaur system is a stand-alone, continuous operation, immunochemistry analyzer. The system performs the following functions.
- aspirates and dispenses samples .
- . performs dilutions
- adds reagents .
- incubates reaction vessels .
- separates solid and liquid waste .
- measures photon emissions .
- performs data reduction .
- collects and maintains patient demographics and results .
This document is a 510(k) summary for the ACS:Centaur Analyzer, an automated immunoassay analyzer. The primary purpose of this document is to demonstrate substantial equivalence to a predicate device, the ACS:180® Analyzer. As such, it focuses on comparing the technological characteristics and intended use rather than providing detailed clinical study results with acceptance criteria.
Therefore, many of the requested sections (Table of acceptance criteria, sample sizes used for test set and data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth used, training set details) cannot be extracted from the provided text. The document does not describe specific acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or studies that prove the device meets such criteria. Instead, it highlights the device's functional capabilities and its similarity to a previously cleared device.
However, based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance:
The document describes functional and technological equivalence to a predicate device rather than specific quantitative performance targets. Therefore, a table of "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial (e.g., sensitivity, specificity) is not explicitly provided. The "acceptance criteria" in this context are implied to be that the ACS:Centaur system performs its intended functions similarly to the predicate device, ACS:180® Analyzer.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Device (ACS:180® Analyzer): | The ACS:Centaur system is a "stand-alone, continuous operation, immunochemistry analyzer" that performs functions like aspirating/dispensing samples, performing dilutions, adding reagents, incubating reaction vessels, separating solid/liquid waste, measuring photon emissions, performing data reduction, and collecting/maintaining patient demographics and results. |
| Technological Equivalence to Predicate Device: | Both ACS:Centaur and ACS:180® utilize "acridinium ester as label and paramagnetic particles as the solid phase." Both "measure the amount of light emitted during the chemiluminescent reaction," with a "direct relationship between the amount of light emitted and amount of antigen in the patient sample." The system supports "competitive binding assays and sandwich assays." It uses a "Master Curve and a two-point, user-initiated calibration" system to eliminate the need for full standard curves or running calibrators with each assay. |
| Specific Technological Features: | Photomultiplier: Used in photon counting mode. |
| Automated Pipetting: For sample and reagents. | |
| Electronic Fluid Sensing: On sample and reagents. | |
| Clog Detection: For samples. | |
| Random Access and Batch Test Processing. | |
| Varied Test Incubations. | |
| Human Interface Features: Barcode reading, LIS integration, automated data reduction. | |
| Automated Dilution Capabilities. | |
| These features collectively represent the device's performance capabilities, which are presented as equivalent or improved compared to the predicate device. The underlying assumption for 510(k) clearance is that these characteristics result in equivalent performance for the stated intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not specified in the provided text. The document describes the device and its intended use but does not detail any specific performance studies or their methodologies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable/Not specified. This document is for an automated immunoassay analyzer, not an imaging device requiring expert interpretation for ground truth. Ground truth for immunoassay devices is typically established through reference methods or established laboratory practices, not expert consensus on qualitative interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not specified. As no specific test set or expert adjudication related to subjective interpretation is mentioned, this information is not present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The ACS:Centaur is an automated immunoassay analyzer, not an AI-assisted diagnostic tool that involves human readers interpreting results in a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device described, the ACS:Centaur, is a standalone automated immunoassay analyzer. Its intrinsic function is to perform tests and provide results without human intervention in the assay execution and initial data reduction. The entire device essentially operates in a "standalone" fashion (algorithm-only if considering the automated testing process as an algorithm). However, the document doesn't detail a specific "standalone performance study" in the context of comparing it against human interpretation, as that's not its intended function. Its performance would be evaluated on its ability to accurately measure biomarkers.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not explicitly stated. For an immunoassay analyzer, ground truth for performance evaluation (e.g., accuracy, precision) would typically be established using reference methods, calibrated standards, or highly characterized biological samples with known analyte concentrations. The document does not detail the specific ground truth methodology used for any performance validation.
8. The sample size for the training set:
Not specified. The document does not refer to a "training set" in the context of machine learning. The "Master Curve" mentioned for calibration might imply a form of system training/calibration, but the sample size for generating this is not provided.
9. How the ground truth for the training set was established:
Not specified. If the "Master Curve" for calibration is considered a form of "training," its ground truth would likely be established using calibrated reference materials or standards with known analyte concentrations. However, the details are not provided.
§ 866.6010 Tumor-associated antigen immunological test system.
(a)
Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.(b)
Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.