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The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma on the Dimension® clinical chemistry system. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients.
The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.

The liquid reagents are configured in an eight well "Flex®"; the content of each Flex® well is described in the Instructions for Use.
The methodology for the Dimension® MPAT assay is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique, which uses a latex particle mycophenolic acid conjugate (PR) and monoclonal mycophenolic acid specific antibody (Ab). Mycophenolic acid present in the sample competes with the mycophenolic acid on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of mycophenolic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
The Dimension MPAT Calibrator is used to calibrate the MPAT assay on the Dimension system. The calibrator is a five level aqueous BSA matrix product containing Mycophenolic acid. The typical calibration levels for levels 1 through 5 respectively, are 0.0, 0.7, 2.3, 6.7 and 30.0 µg/mL. Level 1 is a zero level, and can be used to dilute samples that exceed 30 µg/mL.

Here's an analysis of the provided text to extract the requested information:

Acceptance Criteria and Device Performance Study

The submission focuses on establishing substantial equivalence rather than defining explicit acceptance criteria for a new clinical performance study. The core of the evidence relies on a split-sample comparison to demonstrate agreement with existing, validated methods.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 109 clinical samples
• Data Provenance: Clinical samples from kidney, heart, and liver transplant patients. The country of origin is not specified but is implied to be clinical data. The study is retrospective, as it involves a "split sample comparison" with existing methods, suggesting these samples were collected and then tested by both new and reference methods.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This study does not involve "experts" in the traditional sense of clinicians or radiologists establishing ground truth. Instead, the ground truth is established by reference methods (HPLC/LC-MS assays). The qualifications of the personnel performing these reference assays are not detailed, but it's assumed they are trained laboratory professionals.

4. Adjudication Method for the Test Set

• There was no explicit "adjudication method" described as this was a quantitative comparison against established laboratory reference methods (HPLC/LC-MS). Discrepancies between the new device and the reference method would be analyzed through statistical comparison rather than a consensus process involving multiple human adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test system, not an imaging or diagnostic AI system that would typically involve human readers. The performance is assessed by comparing quantitative results to a gold standard, not by evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Yes, the performance described is effectively "standalone" for the device, meaning it's the performance of the automated assay itself. There is no human-in-the-loop component in the measurement of mycophenolic acid by the Dimension® MPAT system. The device produces a quantitative result without human interpretation of the assay's execution, though a human would interpret the clinical significance of the numerical result.

7. The Type of Ground Truth Used

• Reference Method Assays: The ground truth was established by HPLC/LC-MS assays. These are considered gold standard methods for quantitative measurement of analytes like mycophenolic acid in clinical chemistry.

8. The Sample Size for the Training Set

• The document does not provide information regarding a separate "training set" or its size. For an IVD assay like this, the development process likely involves extensive internal optimization and verification using various samples, but these are generally not described as a distinct "training set" in the context of a 510(k) submission for an immunoassay. The presented data is for the validation of the finalized device.

9. How the Ground Truth for the Training Set Was Established

• Since a specific "training set" is not detailed, this information is not provided. If such a phase existed, the ground truth would similarly be established by robust reference methods or gravimetric preparation of known concentration samples.

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The HbA1c assay used on the Dimension Vista® system is an in vitro diagnostic assay for the quantitative determination of per cent Hemoglobin A1c in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.

HbA 1c calibrator is intended for use in the calibration of the Hemoglobin A 1c (HbA 1c) method on the Dimension Vista® system.

The Dimension Vista® HbA1c kit contains Flex® reagent cartridges and calibrator. Each cartridge contains reagents used to measure total hemoglobin and hemoglobin A1c. the reagents are liquid and ready to use on the instrument. The calibrator in the kit is a five level lyophilized product. Each level is hydrated with 2.0mL of reagent grade water. The lot matched reagents and calibrator product are for use on the Dimension Vista Systems.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Dimension Vista® HbA1c Kit are implicitly established through its substantial equivalence claim to the predicate device and comparison with a reference method. The primary studies focus on method comparison.

124 fresh, EDTA-treated whole blood samples (HbA1c range 3.8 – 16.0 %HbA1c by predicate).

Passing-Bablok regression analysis:

• %HbA1c:
  • Intercept: 0.71 (95% CI: 0.43 to 0.96)
  • Slope: 0.93 (95% CI: 0.89 to 0.97)
• mmol/mol HbA1c:
  • Intercept: 6.13 (95% CI: 3.95 to 7.83)
  • Slope: 0.93 (95% CI: 0.89 to 0.97) |
    | Agreement with a recognized reference method (Tosoh Ion Exchange HPLC analyzer) | Method Comparison (Dimension Vista® HbA1c kit vs. Tosoh Ion Exchange HPLC analyzer):

91 human whole blood samples preserved with EDTA (HbA1c range 4.6 to 9.6 %HbA1c).

Bland-Altman bias analysis:

• Mean Bias: -0.04 %HbA1c

• SD: 0.26 %HbA1c

• Upper 95% CI: 0.47 %HbA1c

• Lower 95% CI: -0.56 %HbA1c

• Tosoh Limits: ±0.75 %HbA1c (indicating the device falls well within acceptable variation from the reference) |
  | Consistency in Intended Use, Sample Type, Technology, Sample Size, Reagents, Calibrator, and Instrument | The document explicitly states the new device has "the same technological characteristics as the Dimension Vista® HA1C kit."

• Intended Use: Both for quantitative measurement of HbA1c in human anticoagulated whole blood on Dimension Vista® systems.

• Sample Type: Both use human anticoagulated whole blood treated with EDTA.

• Technology: Both use turbidometric inhibition immunoassay (TINIA) for HbA1c and modified alkaline hematin reaction for total hemoglobin.

• Sample Size: Both use 1 uL.

• Reagents: Both use similar reagents.

• Calibrator: Both are lyophilized human whole blood hemolysates.

• Instrument: Both used with all Dimension Vista® Systems. |
  | Traceability of Calibrator | Calibrator traceable to NGSP and IFCC (an improvement over the predicate which was only NGSP). |

Here's the additional information requested, based on the provided text:

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set 1 (vs. Predicate Device):
  • Sample Size: 124 fresh, EDTA-treated whole blood samples.
  • Data Provenance: Not explicitly stated, but "fresh, EDTA-treated whole blood samples" usually implies prospective collection from a clinical setting, likely within the country of the manufacturer's operation or study site. However, specific country of origin is not mentioned.
• Test Set 2 (vs. Tosoh HPLC):
  • Sample Size: 91 human whole blood samples preserved with EDTA.
  • Data Provenance: Not explicitly stated, but similar to Test Set 1, likely prospective collection. Specific country of origin is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The ground truth for the test set was established by analytical methods (the predicate device and the Tosoh HPLC analyzer), not by human experts. Therefore, this question is not applicable in this context. The "experts" would be the manufacturers and certified laboratories maintaining the reference methods.

4. Adjudication Method for the Test Set

• No adjudication method is mentioned as the ground truth was established by analytical instruments. This is not applicable to an analytical device comparison.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for image-based diagnostic systems where human readers interpret medical images. This document describes an in vitro diagnostic assay for quantitative laboratory measurements.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, the studies described are of the standalone performance of the Dimension Vista® HbA1c kit. The device performs the measurement quantitatively without direct human intervention in the result generation beyond sample loading and instrument operation. The reported performance metrics (Passing-Bablok regression, Bland-Altman bias) represent the algorithm's (or device's) direct analytical output compared to reference methods.

7. The Type of Ground Truth Used

• The ground truth was established by comparison with established analytical methods:
  • The legally marketed predicate device (Dimension Vista® HA1C kit) for the first comparison.
  • A recognized reference method, the Tosoh Ion Exchange HPLC analyzer, for the second comparison. This HPLC method is a standard for HbA1c measurement and is often considered a higher-level reference.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set" or its size. For an in vitro diagnostic device like this, the development process would involve internal optimization and validation, but a defined "training set" in the context of machine learning (where this term is most common) is not typically described in 510(k) summaries for such devices. The method comparison studies serve as clinical validation.

9. How the Ground Truth for the Training Set Was Established

• As a defined "training set" is not explicitly discussed, the method for establishing its ground truth is not provided. The development and calibration of such assays typically rely on certified reference materials and established laboratory protocols.

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For in vitro diagnostic use in calibrating the following assays using ADVIA Centaur Systems. Enhanced Estradiol (eE2) ADVIA Centaur calibrator 30 is a device intended for medical purposes for use in Estradiol Assay to establish points of reference that are used in the determination of values in the measurement of Estradiol in human serum, Heparinized and EDTA Plasma.

The ADVIA Centaur Calibrator 30 is a 2 level human plasma based solutions containing varying concentrations of Estradiol in charcoal stripped defibrinated human plasma, 0.1% Sodium azide and preservatives. The Estradiol calibrators have expected values of 35 and 2500 pg/mL. The Cal 30 (2.0 mL/vial) is lyophilized. Storage for lyophilized cal is at 2 - 8°C until expiration date specified on label, reconstituted calibrator storage is at 2-80 up to 14 days, and on board is up to 4 hours.

The provided text is a 510(K) Summary for the ADVIA® Centaur Calibrator 30. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study results, acceptance criteria, or information about sample sizes for test/training sets, expert involvement, or MRMC studies that you requested.

The document states: "The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 30 have been validated following procedures of Siemens Healthcare Diagnostics." This indicates that internal validation was performed, but the specific performance metrics and acceptance criteria are not presented in this summary.

Therefore, I cannot fulfill your request for the specific sections as they are not present in the provided text.

Specifically, the following information is missing from the provided text:

1. A table of acceptance criteria and the reported device performance: While the intended use and targeted concentration levels are mentioned, there are no explicit acceptance criteria or detailed performance data presented.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
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, as this is a calibrator, not an AI-assisted diagnostic tool for human readers. This question is designed for AI/imaging devices.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a calibrator, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a calibrator, "ground truth" would typically refer to the accurately assigned values of the analytes. The summary states "value assignment," but doesn't detail the method for establishing that "ground truth."
8. The sample size for the training set: Not mentioned (and likely not applicable in the same way as an AI algorithm, as this is a calibrator solution).
9. How the ground truth for the training set was established: Not mentioned.

Summary of available information related to performance:

• Device: ADVIA Centaur Calibrator 30
• Intended Use: For in vitro diagnostic use in calibrating the Enhanced Estradiol (eE2) assays using ADVIA Centaur systems.
• Predicate Device: ADVIA Centaur Calibrator E (K932715/K954697)
• Performance Statement: "The traceability, value assignment, and stability of the ADVIA Centaur® Calibrator 30 have been validated following procedures of Siemens Healthcare Diagnostics."
• Targeted Concentration of levels: Low = 35 pg/mL, High = 2500 pg/mL (for eE2).

The document's conclusion is that the ADVIA Centaur Calibrator 30 is substantially equivalent to its predicate. This substantial equivalence is based on similarities in intended use (though for a refined analyte), form, matrix, storage, and stability, despite differences in the specific analytes calibrated and their target concentrations. The "performance" section briefly states that validation was done, but does not provide the results of that validation in this public summary.

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