Search Results

For VIDAS H. pylori IgG:
VIDAS® H. pylori IgG (HPY) is an automated qualitative test for use on the instruments of the VIDAS family, for the detection of anti-Helicobacter pylori IgG antibodies in human serum or plasma (EDTA) using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS HPY assay is intended as an aid in diagnosis of H. pylori infection in an adult symptomatic population.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS 3:
The VIDAS 3 system is a complete standalone immunodiagnostic system intended for trained and qualified laboratory technicians (daily routine use) and laboratory administrators (application configuration). This device is an in vitro diagnostic medical device for professional use only.

For VIDAS Lyme IgG II:
The VIDAS Lyme IgG II (LYG) assay is an automated qualitative enzyme immunoassay intended for use on the instruments of the VIDAS family in the presumptive detection of human IgG antibodies to Borrelia burgdorferi in human serum (plain or separation gel) or plasma (sodium heparin). It should be used to test patients with a history and/or symptoms of infection with B. burgdorferi. All VIDAS Lyme IgG II positive specimens should be further tested with a Western Blot IgG assay to obtain supportive evidence of infection with B. burgdorfei. This device is an in vitro diagnostic medical device for professional use only.

For VIDAS RUB IgG:
The VIDAS® RUB IgG (RBG) assay uses Enzyme Linked Fluorescent Assay (ELFA) technology on the instruments of the VIDAS family for the in vitro quantitative measurement of IgG antibodies to rubella virus in human serum. The VIDAS RUB IgG (RBG) assay is intended as an aid in the determination of immune status to rubella. The performance of this device has not been established for screening of cord blood, or for neonatal samples. Likewise, performance characteristics of the assay have not been established for immunocompromised or immunosuppressed individuals.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS TOXO IgM:
The VIDAS® TOXO IgM (TXM) assay is intended for use on the instruments of the VIDAS family (VITEK ImmunoDiagnostic Assay System) as an automated enzyme-linked fluorescent immunoassay (ELF A) for the presumptive qualitative detection of anti-Toxoplasma gondii IgM antibodies in human serum, as an aid in the diagnosis of acute, recent, or reactivated Toxoplasma gondii infection. This assay must be performed in conjunction with an anti-Toxoplasma gondii lgG antibody assay. VIDAS TOXO IgM (TXM) assay performance has not been established for prenatal screening or newborn testing. This assay has not been cleared by the FDA for blood/plasma donor screening. This device is an in vitro diagnostic medical device for professional use only.

For VIDAS Human Chorionic Gonadotropin:
The VIDAS® HCG (HCG) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme linked fluorescent immunoassay (ELFA) for the determination of human Chorionic Gonadotropin (hCG) concentration in human serum or plasma. The VIDAS HCG (HCG) assay is intended to aid in the early detection of pregnancy.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS T4:
The VIDAS® T4 (T4) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyme-linked fluorescent immunoassay for the determination of human thyroxine (T4) concentration in serum or plasma (heparin). It is intended for use as an aid in the diagnosis and treatment of thyroid disorders. This device is an in vitro diagnostic medical device for professional use only.

For VIDAS Testosterone:
The VIDAS Testosterone (TES) assay is an automated quantitative test for use on the instruments of the VIDAS family for the enzyme immunoassay measure of total testosterone in human serum or plasma (lithium heparin), using the ELFA technique (Enzyme Linked Fluorescent Assay). It is intended as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS TSH:
The VIDAS® TSH (TSH) assay is intended for use on the instruments of the VIDAS family as an automated quantitative enzyne-linked fluorescent immunoassay (ELFA) for the determination of human thyroid stimulating hormone- (TSH) concentration in human serum or plasma (heparin). It is intended for use as an aid in the diagnosis of thyroid or pituitary disorders.
This device is an in vitro diagnostic medical device for professional use only.

For VIDAS D-Dimer Exclusion II:
VIDAS® D-Dimer Exclusion II™ is an automated quantitative test for use on the instruments of the VIDAS family for the immunoenzymatic determination of fibrin degradation products (FbDP) in human plasma (sodium citrate, CTAD) using the ELFA technique (Enzyme Linked Fluorescent Assay).
VIDAS D-Dimer Exclusion II is indicated for use in conjunction with a clinical pretest probability assessment model to exclude deep vein thrombosis (DVT) and pulmonary embolism (PE) disease in outpatients suspected of DVT or PE. This device is an in vitro diagnostic medical device for professional use only.

The VIDAS® 3 instrument is an automated multiparametric immunoassay system, which uses ELFA (Enzyme Linked Fluorescent Assay) technology. The VIDAS 3 system offers primary tube sampling, automated sample dilution, reagent/sample detection and reagent traceability.
The technology used, which is adaptable to a wide range of assays, combines the EIA method with a final fluorescence reading: this technology is known as ELFA (Enzyme Linked Fluorescent Assay). The enzyme used in the VIDAS product range is alkaline phosphatase, which catalyzes the hydrolysis of the substrate 4-methyl umbelliferyl phosphate (4-MUP) into a fluorescent product 4-methyl umbelliferone (4-MU) the fluorescence of which is measured at 450nm. The immunological methods are either indirect ElA, immunocapture, sandwich or competition, all involving a conjugate using the alkaline phosphatase.

This document describes the performance data for several VIDAS assays when used on the VIDAS 3 instrument, comparing them to their performance on the predicate VIDAS instrument. The tests are primarily for establishing substantial equivalence for the new VIDAS 3 instrument and do not typically include detailed acceptance criteria for the assays themselves, which are already established for the predicate devices. The studies focus on method comparison, precision, linearity, and detection limits.

Here's a breakdown of the requested information based on the provided text, focusing on the VIDAS H. pylori IgG assay as a primary example, and generalizing for others where appropriate:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a quantitative format for method comparison. Instead, it demonstrates "correlation" and "equivalency" between the new device (VIDAS 3) and the predicate device (VIDAS). For precision, specific CV% ranges are reported.

Here's an example for the VIDAS H. pylori IgG assay's method comparison:

Note: For quantitative assays like VIDAS RUB IgG, VIDAS HCG, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II, method comparison relies on slope, intercept, and correlation coefficient, implying acceptance criteria for these values (e.g., slope close to 1, intercept close to 0, high correlation coefficient). Precision for these assays also includes CV% for various components.

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

• VIDAS H. pylori IgG:

  • Test Set Size: 250 serum samples (positive, equivocal, and negative).
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study compares performance between two instruments, implying samples are run on both.

• VIDAS Lyme IgG II:

  • Test Set Size: 220 serum samples (positive and negative).
  • Data Provenance: Not explicitly stated.

• VIDAS RUB IgG:

  • Test Set Size (Quantitative Method Comparison): 112 serum samples (ranging from 0 to 225 IU/mL).
  • Test Set Size (Qualitative Method Comparison): 220 serum samples (positive, equivocal, and negative).
  • Test Set Size (CDC Reference Panel): 100 specimens (50 pairs of sera).
  • Data Provenance: Not explicitly stated for general samples. The CDC panel implies a curated and standardized set.

• VIDAS TOXO IgM:

  • Test Set Size: 198 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS Human Chorionic Gonadotropin (hCG):

  • Test Set Size: 113 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS T4:

  • Test Set Size: 105 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS Testosterone:

  • Test Set Size: 172 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS TSH:

  • Test Set Size: 179 serum samples.
  • Data Provenance: Not explicitly stated.

• VIDAS D-Dimer Exclusion II:

  • Test Set Size: 219 plasma samples.
  • Data Provenance: Not explicitly stated.

Across all assays, the studies are described as "Method Comparison" and "Precision" studies, which are typically retrospective analyses of patient samples to compare device performance to an established method.

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

This information is not provided in the document. For in vitro diagnostic devices, ground truth is typically established by comparative methods (e.g., predicate device, reference methods, clinical diagnosis, or other laboratory gold standards) rather than expert consensus on individual cases. The document states that performance was evaluated against the predicate device (e.g., "VIDAS H. pylori IgG assay on the VIDAS 3 to the VIDAS H. pylori IgG assay on the VIDAS"). The "ground truth" for these studies is the result obtained from the predicate VIDAS instrument using its established methodology.

For the VIDAS RUB IgG, a "CDC reference panel" and "CDC low-titer rubella antibody standard" are mentioned, where the reference panel sera were "titered by Hemagglutination Inhibition." This implies that the ground truth for this specific part of the study was established by a recognized reference method (Hemagglutination Inhibition) and certified reference materials from the CDC.

4. Adjudication Method for the Test Set

This information is not explicitly provided. For method comparison studies, typically, discordant results between the new device and the predicate device (or reference method) are investigated. However, the exact adjudication process (e.g., by a third, more definitive test, or expert review of patient clinical history) is not detailed. The phrase "results were evaluated according to CLSI EP12-A2" or CLSI EP9 suggests standard statistical methods for agreement or correlation, which do not necessarily involve expert adjudication of individual discrepancies beyond reporting them.

For quantitative assays where method comparison statistics (slope, intercept, correlation coefficient) are used, "outliers" were removed in some cases (e.g., VIDAS RUB IgG quantitative comparison), implying some form of review or statistical exclusion, but not necessarily expert "adjudication" in the sense of clinical decision-making.

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

No. This document describes performance studies for in vitro diagnostic instruments and assays, not imaging or similar devices that would typically involve human readers interpreting results. Therefore, an MRMC comparative effectiveness study, which assesses improvements in human interpretation with AI assistance, is not applicable and was not performed.

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

The studies described are for the standalone in vitro diagnostic instruments and their associated assays. These are standalone tests, meaning the algorithm (or assay chemistry in this case) processes the sample and provides a result without direct human interpretation of raw data for diagnosis. The "human-in-the-loop" here refers to trained laboratory technicians operating the instrument and interpreting the final quantitative or qualitative results according to established cut-offs/guidelines, rather than interpreting complex images or signals. The purpose of these studies is to confirm that the new instrument (VIDAS 3) produces equivalent results to the predicate instrument (VIDAS) for these assays.

7. The Type of Ground Truth Used

The primary type of "ground truth" used in these studies is the results obtained from the predicate device (VIDAS instrument) for the same assays. The goal is to demonstrate "substantial equivalence" of the new instrument (VIDAS 3) to the predicate.

For the VIDAS RUB IgG assay, a CDC reference panel where samples were "titered by Hemagglutination Inhibition" served as an additional, external reference for ground truth in a specific subset of testing. This is a form of reference method/standardized panel data.

8. The Sample Size for the Training Set

This information is not explicitly provided in the document. For in vitro diagnostic assays, "training sets" are usually involved in the initial development and optimization of the assay itself (e.g., establishing reagents, parameters, cut-offs). The studies described in this document are focused on the validation and verification of the new instrument's performance with existing, already developed assays, often referred to as "test sets" or "evaluation sets." The assays themselves were presumably developed and "trained" using various sample sets prior to these studies.

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

Since information on a distinct "training set" for the new instrument's validation isn't provided (as the assays were pre-existing), details on its ground truth establishment are also not available in this document. For the development of the original assays, ground truth would have been established through a combination of clinical diagnoses, established reference methods, and correlation with disease status.

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The VIDAS® TOXO IgG Avidity assay is an automated qualitative test for the determination of anti-toxoplasma IgG avidity in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® TOXO IgG Avidity assay is intended for use in conjunction with results from the VIDAS TOXO IgG II and must have a positive titer (> 8 IU/mL); other laboratory findings and clinical information to aid in the presumptive exclusion of a recently acquired (

The VIDAS® TOXO IgG Avidity assay is an automated qualitative test for the determination of anti-toxoplasma IqG avidity in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS® TOXO IgG Avidity assay is intended for use in conjunction with results from the VIDAS TOXO IqG II and must have a positive titer (> 8 IU/mL); other laboratory findings and clinical information to aid in the presumptive exclusion of a recently acquired (

The provided document describes the VIDAS® TOXO IgG Avidity Assay, an automated qualitative test for determining anti-toxoplasma IgG avidity in human serum. It is intended to aid in the presumptive exclusion of a recently acquired (≤ 4 months) Toxoplasma gondii infection in pregnant women and patients with lymphadenopathy, in conjunction with other laboratory and clinical findings.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as clear numerical targets. Instead, it presents several analytical performance metrics for the VIDAS® TOXO IgG Avidity Assay, which inherently serve as the data demonstrating its performance. For comparison, the document also includes data for the predicate device, VIDAS® TOXO IgM Assay.

2. Sample Size for the Test Set and Data Provenance

The document refers to "non-clinical (analytical) comparison" data, which typically represents testing done for analytical performance rather than clinical validation of diagnostic accuracy with patient samples.

• Precision Studies:
  • Within-run Precision: n = 80 replicates at each of 3 sites (total 240 replicates per avidity level).
  • Between-Run Precision: n = 40 runs at each of 3 sites.
  • Total Precision: n = 120 runs (2 runs per day, for 10 days with 2 reagent lots, at 3 sites).
• Cross-Reactivity: Number of samples varies by condition (e.g., 12 samples tested for HSV-1 disease, others are not specified with counts beyond "samples from patients with...").
• Interfering Substances: Not specified with sample counts but indicates testing was done up to certain concentrations.
• Drug Interference: Not specified with sample counts but indicates testing was done at specific drug concentrations.

Data Provenance: The document does not explicitly state the country of origin for the samples or if the data is retrospective or prospective. It is clinical laboratory data, generated during the analytical validation of the assay.

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

The document describes analytical performance studies (precision, cross-reactivity, interference). For these types of analytical studies, the "ground truth" is typically defined by controlled experimental conditions (e.g., known concentrations, spiked samples, well-characterized panels) rather than expert clinical consensus. Therefore, expert involvement for establishing ground truth in this context is not applicable.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies to establish a consensus ground truth from multiple expert readings of patient cases. Since this document focuses on analytical performance rather than diagnostic accuracy with expert-adjudicated clinical cases, no such adjudication method is mentioned or relevant to the data presented.

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

No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies detailed are analytical performance evaluations of the assay itself, not studies comparing human reader performance with or without AI assistance. The device is a diagnostic assay, not an AI-powered image analysis tool or decision support system for human readers.

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

Yes, the studies presented are standalone performance evaluations of the VIDAS® TOXO IgG Avidity Assay. The assay is an automated qualitative test that provides results directly. The analytical performance data (precision, cross-reactivity, interference) are all measures of the algorithm's/device's performance without human intervention in the result determination. The document states, "All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. During the final detection step... results are automatically calculated by the instrument and then printed out."

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the analytical studies presented, the "ground truth" was established by:

• Known Characteristics of Controls/Samples: For precision studies, standardized controls or characterized samples with known avidity levels were used.
• Known Presence/Absence of Interferents/Cross-Reactants: For cross-reactivity and interference studies, samples were either known to contain specific cross-reactants/interferents or were spiked with them at defined concentrations.

This type of ground truth is based on the intrinsic properties of the test materials and the controlled experimental setup, which is standard for analytical validation of in vitro diagnostic devices. Clinical ground truth (e.g., confirmed toxoplasmosis infection status based on pathology or long-term clinical outcome) would be established in a clinical performance study, which is distinct from the analytical studies described here.

8. The Sample Size for the Training Set

The document describes pre-market analytical performance data for a diagnostic assay. It does not mention a "training set" or "test set" in the context of machine learning or AI development. The data presented are from validation studies of the finished device. Therefore, information on a training set size is not applicable in this context.

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

As explained in point 8, the concept of a "training set" for an AI or machine learning model is not applicable to the analytical validation of this in vitro diagnostic assay.

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