Search Results

Dimension Vista® HCYS Flex® reagent cartridge: The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum, heparinized and EDTA plasma on the Dimension Vista® System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Dimension Vista® Protein 1 Calibrator: PROT 1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Homocysteine (HCYS), Immunoalobulin A (IGA). Immunoalobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

Dimension Vista® Protein 1 Control L, M and H: PROT1 CON L. M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista®.

Dimension Vista® HCYS Flex® reagent cartridge: Bound homocysteine in the sample is reduced to free homocysteine by the action of dithiothreitol, and then converted enzymatically to S-adenosyl-homocysteine (SAH). Conjugated S-adenosylcysteine (SAC), added at the onset of the reaction, competes with the SAH in the sample for bonding by anti-SAH antibodies bound to polystyrene particles. In the presence of SAH, there is either no aggregation or a weak aggregation of particles. In the absence of SAH in the sample, an aggregation of the polystyrene particles by the conjugated SAC occurs. The higher the SAH content of the reaction mixture, the smaller the scattered light signal. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista® Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3, C4. Homocysteine (HCYS). Immunoalobulin A (IGA). Immunoalobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

Dimension Vista® Protein 1 Control L, M and H: Protein 1 Control L. M and H are multi-analyte, liguid, human serum based products containing C3, C4, Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

The provided text describes a 510(k) summary for new in-vitro diagnostic products: the Dimension Vista® HCYS Flex® reagent cartridge, Dimension Vista® Protein 1 Calibrator, and Dimension Vista® Protein 1 Control L, M and H. The primary focus of the performance data in the submission is for the Dimension Vista® HCYS assay.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in the form of numerical thresholds or targets for the method comparison study. Instead, it relies on demonstrating correlation and equivalent performance to a legally marketed predicate device.

The reported device performance in the method comparison study showed:

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

• Sample Size: 215 serum and plasma samples.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). However, it's implied to be laboratory-based testing of patient samples.

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

This type of information is generally not applicable to a submission for an in-vitro diagnostic assay like the Dimension Vista® HCYS. The "ground truth" for these types of assays is typically established by measurements from a reference method or a legally marketed predicate device, rather than by expert consensus on image interpretation or clinical diagnosis.

4. Adjudication Method for the Test Set

Not applicable. The study is a method comparison between two quantitative assays, not an adjudicated diagnostic study.

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. This submission is for an in-vitro diagnostic reagent and calibrator/controls, not an AI-assisted diagnostic tool that would involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a form of standalone performance was done for the Dimension Vista® HCYS assay. The study directly compared the new device's measurements (algorithm only in the context of the instrument) against the predicate device's measurements, without human interpretation of the results from either system.

7. The Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device: the Dade Behring N Latex HCY assay on the BN ProSpec® System. This is a common approach for demonstrating substantial equivalence for new in-vitro diagnostic devices.

8. The Sample Size for the Training Set

The document does not mention a separate "training set" in the context of machine learning or AI. For an in-vitro diagnostic assay, the "training" (e.g., optimization and validation of the assay's reagents and methodologies) would occur internally during product development, prior to the submission of performance data. The reported "215" samples are for the method comparison study, which serves as a validation/test set.

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

As no explicit "training set" in the AI/ML context is mentioned, this question is not directly applicable. For the development of the assay, calibration and reference materials would have been used, with their values likely established through robust analytical methods and traceability to higher-order reference materials or methods.

Ask a specific question about this device