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510(k) Data Aggregation
(63 days)
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
The Bayer ADVIA Centaur assay is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.
The ADVIA 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 wastes ●
- Measures photon emissions .
- Performs data reduction ●
- Collects and maintains patient demographics and results .
The provided text describes a 510(k) summary for the ADVIA® Centaur automated immunoassay analyzer. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results as would be found for a new diagnostic device or algorithm.
Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, and expert involvement is not available within this 510(k) summary. The document highlights the technological characteristics of the device and compares them to its predicate.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the way typically expected for a clinical performance study. The 510(k) summary focuses on demonstrating substantial equivalence based on technological characteristics and intended use to a predicate device (ADVIA Centaur V2.5). The performance implied is that the new version (V3.0) performs equivalently to the predicate.
The table in the document compares "Features" of ADVIA Centaur V2.5 (K032525) and ADVIA Centaur V3.0. For almost all features, the entry for V3.0 is "same", implying that the performance related to these features is considered equivalent to the predicate. The only differences mentioned are software enhancements and hardware improvements.
| Feature Type | Acceptance Criteria (Implied for V3.0) | Reported Device Performance (ADVIA Centaur V3.0) |
|---|---|---|
| Principles of Operation | Must be same as predicate (Chemiluminescence, magnetic-particle solid phase, chemiluminescent label) | Same as predicate |
| Optical System | Must be same as predicate (PMT in photon counting mode) | Same as predicate |
| Temp control | Must be same as predicate (Reactions at 37°C, reagents at 4°C-8°C) | Same as predicate |
| Dispense System | Must be same as predicate (Automated pipetting, precision syringes) | Same as predicate |
| Sample Probe | Must be same as predicate (Air pressure fluid/tip sensing, clog detection) | Same as predicate |
| Reagent Probes | Must be same as predicate (No level sense, fluid monitoring) | Same as predicate |
| Reagent and Sample Handling | Must be same as predicate (5 tube racks, 180 samples, 30 reagent positions, refrigeration) | Same as predicate |
| Test Processing | Must be same as predicate (Random Access and Batch, continuous operation, throughput optimization) | Same as predicate |
| Assay Protocols | Must be same as predicate (Various incubation times and steps) | Same as predicate |
| Human Interface - Data Output | Must be same as predicate (17" monitor, external printers, LIS, beeper, remote diagnostics) | Same as predicate |
| Human Interface - Data Input | Must be same as predicate (Keyboard, barcode readers, LIS) | Same as predicate |
| Human Interface - Data Analysis | Must be same as predicate (Automated data reduction) | Same as predicate |
| QC Software | Must be same as predicate (Assay-specific data reduction, stored controls, L-J plotting, statistical enhancements, CCD compatibility) | Same as predicate, with added "New Features to QC Functionality" |
| Specimens | Must be same as predicate (Serum/plasma, dilutions allowed) | Same as predicate |
| Disposables | Must be same as predicate (Sample cups, reaction cuvettes, pipette tips, loaded during run) | Same as predicate |
| Reagents | Must be same as predicate (Solid phase, Acridinium Ester, volume reporting, inventory tracking) | Same as predicate |
| Calibrators | Must be same as predicate (6-10 point stored, 2-point user, barcode check, lot number storage) | Same as predicate |
| Controls | Must be same as predicate (Low/mid/high, capability to dilute) | Same as predicate |
| Physical | Must be same as predicate (Size, weight, power, ambient temp) | Same as predicate |
| Laboratory Automation | Must be same as predicate (Software signals for direct sampling from transport system) | Same as predicate |
| Other User Interface Features | Must be same as predicate (Stat interrupt, auto cleaning, GUI, system status, foreign languages, multiple barcode formats, on-line help, system test extended) | Same as predicate (with extended system test including slope, offset, dilution, overrange) |
| Other Performance Features | Must be same as predicate (Throughput: 120-240 tests/hr, Time to First Result: 15-60 min, On-board supplies for 1000 tests) | Same as predicate |
| Software | Unix-based GUI, multiple distributed real-time computing platforms, LIS/LAS communication | Same as predicate, plus "Control Bracketing Software", "Restricted Test Mode", "Transmission of Ratio Component", "Repeat with Replicates", "New Reports" |
| Hardware Improvements | Hitachi/Universal rack option, High Resolution Barcode Scanner (LS4000i) | Same as predicate (these were present in the predicate V2.5 as well, indicating they were features of K032525) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided 510(k) summary. 510(k) submissions for automated analyzers like this typically focus on technical specifications and functional equivalence rather than clinical performance studies with specific patient sample test sets unless there's a novel assay or a significant change to existing assays. The comparison is feature-based against the predicate device.
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)
This information is not applicable/available. The document does not describe a clinical study requiring ground truth establishment by experts for a test set. This is a submission for an automated immunoassay analyzer, not an imaging device or diagnostic algorithm that relies on expert interpretation of results for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/available. There is no described test set or clinical study requiring adjudication.
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
This information is not applicable. The device is an automated immunoassay analyzer, not an AI-assisted diagnostic tool that involves human readers or interpretation of cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The ADVIA® Centaur system is inherently a standalone automated analyzer. Its performance is measured by its ability to accurately and precisely execute immunoassay analysis. The document implicitly supports this by stating it "performs the following functions" (aspirates, dispenses, adds reagents, incubates, separates, measures photon emissions, performs data reduction, collects and maintains data). The comparison to the predicate focuses on its ability to perform these functions similarly ("same").
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/available for the device itself in this context. For immunoassay analyzers, "ground truth" typically refers to the known concentrations of analytes in reference materials (calibrators, controls) or validated reference methods for patient samples, which are used to establish accuracy, precision, and linearity of the assays run on the system. The 510(k) summary does not detail the validation studies for specific assays run on the Centaur. It only states the system uses a "Master Curve and a two-point, user-initiated calibration."
8. The sample size for the training set
This information is not applicable/available. This 510(k) submission is for an updated version of an automated immunoassay analyzer, not an AI/ML device that requires a "training set" in the computational sense.
9. How the ground truth for the training set was established
This information is not applicable/available for the same reason as point 8.
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(25 days)
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
The Bayer ADVIA Centaur is an automated immunoassay analyzer designed to perform in vitro diagnostic immunochemical assay analysis on clinical specimens. The system menu will include endocrine, anemia, allergy, reproductive, cardiovascular, oncology, adrenal, bone metabolism, therapeutic drug, and infectious disease assays. All assays are based on chemiluminescent technology.
The ADVIA 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 wastes
- Measures photon emissions .
- Performs data reduction
- Collects and maintains patient demographics and results ●
The provided text is a 510(k) Summary for the Bayer ADVIA Centaur, an automated immunoassay analyzer. This type of document focuses on establishing substantial equivalence to a predicate device based on technological characteristics and intended use, rather than conducting new clinical performance studies with acceptance criteria, ground truth, and expert evaluation as would be seen for novel diagnostic devices.
Therefore, the provided text does not contain the kind of detailed information requested for a clinical study proving a device meets acceptance criteria. Specifically, it lacks:
- Explicit acceptance criteria: There is no table detailing specific performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet.
- A "study" proving acceptance criteria: The document focuses on demonstrating that the ADVIA Centaur is technologically equivalent to its predicate (ACS Centaur V1.0), implying that its performance will be similar, but it does not present a standalone clinical study with an associated test set, ground truth, or expert review.
- Sample size for test set, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set details. These are all elements of a clinical validation study, which is not presented here.
Based on the provided text, I can only provide the following, which is largely descriptive of the device and its predicate equivalence rather than a performance study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not include specific acceptance criteria with quantitative performance targets (e.g., sensitivity, specificity, accuracy, precision ranges, etc.) for the ADVIA Centaur beyond the general equivalence to the predicate device. The "performance" described is largely a comparison of technological features to the predicate, implying similar performance.
| Feature | Predicate Device (ACS Centaur V1.0) | ADVIA Centaur V2.5 (Reported Performance/Characteristics) |
|---|---|---|
| Principles of Operation | Chemiluminescence using magnetic-particle solid phase and chemiluminescent label | Same |
| Optical System | PMT used in photon counting mode | Same |
| Temperature Control | Reactions are controlled at 37°C; Reagent Storage: 4°C to 8°C | Same |
| Dispense System | Automated pipetting of samples and reagents; Precision syringes; Sample Probe: Air pressure fluid sensing, Air pressure disposable tip sensing, Clog detection mechanism; Reagent Probes: No level sense, fluid monitoring during aspiration | Same |
| Reagent and Sample Handling | Samples: 5 tube racks, up to 180 samples; Tube size selected by barcode; Assay Reagents: Reagent Tray with 30 positions, Refrigeration, Pack contains Solid Phase and Tracer Reagent; Ancillary Reagents: Reagent Compartment with 15 positions, Refrigeration | Same |
| Test Processing | Random Access and Batch; Sample scheduling optimized for throughput; Continuous Operation | Same |
| Assay Protocols | 7.5 min, single step; 20 min, single step; 7.5-20 min, two step; 20-20 min, two step | Same |
| Human Interface - Data Output | 17" Color Monitor with GUI; External printers; Serial bi-directional LIS Interface; Audible beeper; Computer LIS Interface; External Modem for Remote Diagnostics Interface | Same |
| Human Interface - Data Input | 101 key keyboard; Hand-held barcode reader; Stationary barcode scanners for patient samples; Moving Barcode reader for primary reagents; Computer LIS Interface | Same, with "LIS Software, additional features" (e.g., enhanced LIS) |
| Human Interface - Data Analysis | Automated data reduction; Assay-specific data reduction | Same |
| QC Software | Stored control results; L-J plotting; Statistical enhancements; Compatibility with CCD QC Reporting | Same, with "Added New Features to QC Functionality" (e.g., likely enhanced, but specifics not detailed) |
| Specimens | Serum or plasma, sample cups or primary tubes; Dilutions allowed on a per-assay basis; Capability of Dilution of Samples Requiring Pretreatment | Same |
| Disposables | Sample cups; Reaction cuvettes; Cuvette loading/unloading during run; Reagent 1 & 2 status tracked/displayed; Time to First Result: 15, 30, 60 min (assay-dependent); On-board supplies for 1000 tests | Same |
| Additional Features | N/A | Added diagnostic tools |
| Software | Unix based GUI, Multiple distributed real-time computing platforms, LIS/LAS communication | Same, except for "additional features" including "New Reports-maintenance, event log, reagent tracking. Screen Saver added. New Exit queue status window." |
| Hardware Improvements | ACS Centaur System | Same, except for enhancements: "New UI Module with increased capacity. Hitachi/Universal rack option added. High Resolution Barcode Scanner (LS4000i) released." |
2. Sample Size for Test Set and Data Provenance
Not applicable. The document describes a substantial equivalence submission, not a clinical performance study with a distinct "test set" in the context of diagnostic accuracy. The data provenance and sample sizes for any underlying validation studies that led to the predicate's original clearance or the ADVIA Centaur's internal verification are not detailed here.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This information pertains to a clinical validation study where ground truth is established by experts (e.g., radiologists, pathologists). The 510(k) summary focuses on comparing technical specifications.
4. Adjudication Method
Not applicable. This is relevant for expert-adjudicated ground truth in clinical studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study assesses how AI intervention affects human reader performance. The ADVIA Centaur is an automated immunoassay analyzer, not an AI-powered image analysis or diagnostic aid designed to assist human readers. It performs tests on its own.
6. Standalone Performance Study
Yes, implicitly. The very nature of an automated immunoassay analyzer means it operates in a standalone fashion, providing results without direct human intervention in the analytical process. Its "performance" is demonstrated by its technical specifications and equivalence to the predicate, which implies its ability to accurately measure analytes in samples independently. However, specific standalone quantitative performance metrics (e.g., analytical sensitivity, specificity, imprecision, accuracy against a reference method) are not detailed in this summary; they would be found in detailed validation reports or product labeling.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied in AI/diagnostic imaging studies (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. For an immunoassay analyzer, the "ground truth" for its analytical performance would be established through:
- Reference methods: Comparisons to established, highly accurate laboratory methods for measuring analytes.
- Certified reference materials/standards: Testing samples with known, certified concentrations of the analytes.
- Clinical correlation: Showing that results from the device correlate well with clinical diagnoses or patient outcomes, although this is more for clinical utility than analytical accuracy.
This 510(k) summary does not specify which of these were used, nor does it present the results of such studies.
8. Sample Size for the Training Set
Not applicable. This device is an immunoassay analyzer and does not utilize a "training set" in the machine learning sense. Its operation is based on established chemiluminescent technology and predefined assay protocols, not trainable AI models.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device.
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