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The LIAISON® H. pylori IgG assay uses chemiluminescent immunoassay (CLIA) technology for the qualitative determination of IgG antibodies to Helicobacter pylori in human serum from symptomatic adults as an aid in the diagnosis of Helicobacter pylori infection. Assay results should be used in conjunction with other clinical or laboratory data to assist the clinician in making individual patient management decisions. The test has to be performed on the LIAISON® XL Analyzer.

The LIAISON® H. pylori IgG Control Set is intended for use as assayed quality control samples to monitor the performance of the LIAISON® H. pylori IgG assay.

The method for qualitative determination of IgG antibodies to Helicobacter pylori (H.pv/ori IgG) is a two-step, indirect chemiluminescence immunoassay (CLIA). The principal components of the test are magnetic particles (solid phase) coated with Helicobacter pylori antigen and a conjugate of anti-human IgG monoclonal antibodies to linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, H. pylori antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the monoclonal antibody conjugate reacts with H. pylori lgG that is already bound to the solid phase. After each incubation, unbound material is removed with a wash cycle.

Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and therefore, the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of H. pylori IgG in calibrators, samples or controls.

All assay steps and incubations are performed by the LIAISON® XL Analyzer.

The provided text describes a 510(k) premarket notification for the "LIAISON® H. pylori IgG" assay, an in vitro diagnostic device. This document focuses on demonstrating the substantial equivalence of the new device to a legally marketed predicate device (Siemens IMMULITE 2000 H. pylori IgG Assay).

Here's an analysis of the acceptance criteria and study data based on the provided text, using the requested framework:

Acceptance Criteria and Device Performance

The document doesn't explicitly state "acceptance criteria" in a table format with specific numerical targets. Instead, it presents performance data for comparison against a predicate device. The implied acceptance criteria are that the new device's performance (specifically, accuracy as measured by percent agreement) is comparable to that of the predicate device within acceptable statistical variation.

Here's a table summarizing the reported device performance, which serves as evidence of meeting the implied acceptance criteria for equivalence:

Table 1: Device Performance (Comparative Clinical Study)

Note: The document also includes extensive precision/reproducibility data (Within-Laboratory Precision and Reproducibility at multiple sites), which are crucial for establishing the reliability and consistency of the assay. While not direct "acceptance criteria" in terms of accuracy against a true disease state, these data demonstrate the device's analytical performance meets expected standards for an in vitro diagnostic.

Study Details

Here's a breakdown of the specific information requested, based on the provided text:

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

• Sample Size: 504 samples
• Data Provenance:
  • Country of Origin: Multiple geographical locations in the U.S.
  • Retrospective or Prospective: Prospective study. Samples were collected from non-selected adult subjects sent to the laboratory for H. pylori IgG serological testing.

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

• Not Applicable / Not Provided: For this type of in vitro diagnostic device (immunoassay for antibodies), the "ground truth" for the comparative clinical study is established by the results of a legally marketed predicate device, not by expert interpretation of images or other clinical data. Hence, there is no mention of experts establishing a ground truth in the context of radiologists or similar clinical reviewers.

4. Adjudication Method for the Test Set:

• Not Applicable / Not Provided: Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving human interpretation (e.g., image reading) where there might be disagreement. In this comparative study with a predicate device, the comparison is directly between the new device's results and the predicate device's results, with no mention of human adjudication of results. The "ground truth" is effectively the predicate device's result.

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:

• No: An MRMC comparative effectiveness study is not applicable as this is an in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers. The device performs the test autonomously.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes: This device (LIAISON® H. pylori IgG assay) is inherently a standalone diagnostic test. Its performance is evaluated based on its ability to detect antibodies independently. The clinical study compares its standalone performance against another standalone device (the predicate).

7. The Type of Ground Truth Used:

• Predicate Device Results: For the comparative clinical study, the "ground truth" against which the LIAISON® H. pylori IgG assay was evaluated was the results from the FDA-cleared predicate device (Siemens IMMULITE 2000 H. pylori IgG Assay).

8. The Sample Size for the Training Set:

• Not Applicable / Not Provided: This is an immunoassay, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The development of reagents and assay parameters is based on biochemical and analytical principles, not on training data in the way an AI model would be.

9. How the Ground Truth for the Training Set was Established:

• Not Applicable / Not Provided: As noted above, there is no "training set" in this context. The assay's performance characteristics (e.g., cutoff values) are established through analytical validation and optimization, often against known positive and negative samples, but not through a "ground truth" establishment process for a training set as would be done for an AI algorithm.

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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 Helicobacter pyloxi IgG ELISA test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human IgG class antibodies to Helicobacter pylori in serum and in EDTA or heparin-treated plasma. The test is intended to aid in the diagnosis of Helicobacter pylori infection in adult patients with clinical symptoms of gastritis. FOR INVITRO DIAGNOSTIC USE.

The Helicobacter pylori IgG ELISA is an immunoassay to detect IgG antibodies to Helicobacter pylori. The assay requires a total of 90-minutes incubation. The test uses partially purified Helicobacter pylori bacterial antigen adsorbed to a solid phase microassay well. Prediluted test serum or plasma is added to each well and incubated for 30 minutes at 37℃. If Helicobacter pylori-specific IgG antibodies are present, they will bind to the antigen in the well. After the incubation, the wells are washed three times to remove any unbound serum or plasma. An HRP-conjugated monoclonal anti-human IgG is added to each well, and the test is incubated for 30 minutes at 37℃. If Helicobacter pylori antibody is present, it will bind to the antibody attached to the antigen on the well. The wells are washed again to remove any unbound conjugate. A TMB-substrate is added to each well and incubated for 30 minutes at room temperature (20-25°C). If enzyme is present, it will react with the substrate to generate a colored product. After the incubation period, the reaction is stopped with a Stop Solution and the color intensity is measured spectrophotometrically. The Helicobacter pylori IgG ELISA is highly sensitive for the detection of IgG antibodies to Helicobacter pvlori in serum or plasma samples.

Here's a breakdown of the acceptance criteria and study details for the Biohit Helicobacter pylori IgG ELISA, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document does not explicitly state pre-defined acceptance criteria in terms of target percentages for sensitivity, specificity, or agreement. Instead, it reports the device's performance when compared to two different reference methods: histology (considered the "gold standard") and a legally marketed predicate ELISA. The conclusion for substantial equivalence is based on these reported performance metrics aligning with clinical expectations for such a device.

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample size of the test set or the provenance of the data (country of origin, retrospective/prospective). It simply refers to "clinical evaluations" and comparison studies.

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)

The document does not specify the number of experts or their qualifications for establishing the ground truth. It states that "Culture of the organism and/or histologic staining from a biopsy sample obtained at endoscopy is considered by the FDA to be the current 'Gold Standard' for detection of Helicobacter pylori". This implies a reliance on standard laboratory procedures and interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for the test set. The ground truth was established by "Gold Standard" methods (histology) and comparison to a commercial ELISA.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an immunoassay (ELISA) for detecting antibodies, not an imaging or diagnostic algorithm requiring human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The entire study reported describes the standalone performance of the Biohit Helicobacter pylori IgG ELISA kit. This device is an in vitro diagnostic test, meaning its output is a direct result from the assay and does not involve a human-in-the-loop interpretation for its primary function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The primary ground truth used was histology of biopsy samples, which is considered the "Gold Standard" by the FDA for the detection of Helicobacter pylori. Bacterial culture of biopsy samples is also mentioned as a "Gold Standard" method. The study also uses a legally marketed commercial enzyme immunoassay (IMMULITE® Helicobacter pylori IgG) as a comparative reference.

8. The sample size for the training set

The document does not provide information about a separate training set or its sample size. This is typical for a diagnostic kit submission, where development and internal validation (which might involve a "training" phase) are distinct from the clinical performance study reported for regulatory submission.

9. How the ground truth for the training set was established

Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided. The ground truth methods for the performance evaluation set are as described in point 7.

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The Trinity Biotech Captia™ H. pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to Helicobacter pylori, as an aid in the diagnosis of H. pylori infection in adult patients with clinical signs and symptoms of gastrointestinal disease, and is not intended for use in asymptomatic patients.

The H. pylori IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to antigen. The Trinity Pylori IgG ELISA assay may be used as an aid in the diagnosis of Helicobacter pylori infection in persons with gastrointestinal symptoms. For In Vitro Diagnostic Use Only.

The H. pylori IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Helicobacter pylori. Purified Helicobacter pylori antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period, the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

The provided document is a 510(k) premarket notification for the Trinity Biotech H. pylori IgG ELISA test kit. It describes the device, its predicate device, and performance characteristics, but does not explicitly state formal acceptance criteria. However, we can infer the performance targets based on the comparison to the predicate device and the presented results.

Here is an analysis based on the provided information:

Acceptance Criteria and Reported Device Performance

Note on Inferred Acceptance Criteria: The document primarily demonstrates substantial equivalence to "biopsy" (culture or stain) and to a predicate device (Pylori Stat). Therefore, the "acceptance criteria" are implicitly met if the performance characteristics are deemed substantially equivalent to these established methods. The exact numerical thresholds for acceptance are not explicitly listed, but the device's performance falling within the confidence intervals and showing high agreement suggests it met the unstated bar for equivalence.

Study Details

1. Sample size used for the test set and the data provenance:

   • Pylori Stat (Predicate Device) Evaluation: 386 serum samples.
     • Data Provenance: From five geographically different areas.
     • Retrospective/Prospective: Not explicitly stated, but samples were "having biopsy with stain or culture results," suggesting a retrospective collection of samples with known outcomes.
   • Trinity Biotech H. pylori IgG ELISA Evaluation: 371 serum samples.
     • Data Provenance: From five geographically different areas.
     • Retrospective/Prospective: Not explicitly stated, but samples were "having biopsy with stain or culture results," suggesting a retrospective collection of samples with known outcomes.
   • Precision Test: Six different serum samples, each tested ten times over three days (total of 180 individual tests for CV calculation).
   • Cross-Reactivity Test: Paired sera from 5 C. jejuni infections, 4 single sera from C. fetus infections, and 10 sera positive for Borrelia burgdorferi.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The ground truth for the test set was established by "biopsy with stain or culture results for H. pylori."
   • The document does not specify the number of experts, their qualifications (e.g., pathologist, microbiologist), or the process involved in interpreting these biopsy/culture results.

3. Adjudication method for the test set:

   • The document explicitly states that "Equivocals were not included in the above calculations" for sensitivity, specificity, and agreement calculations. This implies that any samples yielding "equivocal" results from the ELISA tests were excluded from the primary performance metrics. There is no mention of an adjudication process to re-classify these equivocal results or conflicting ground truth interpretations.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This report describes the performance of an in vitro diagnostic (IVD) ELISA kit, which is a laboratory test, not an AI-assisted diagnostic tool for human readers. Therefore, there is no "human readers improve with AI vs without AI assistance" component.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Yes, a standalone performance study was done. The entire evaluation of the Trinity Biotech H. pylori IgG ELISA against biopsy and against the predicate device is a standalone performance assessment of the diagnostic kit itself, without human interpretation influencing the test result once the serum is processed by the ELISA method. The "interpretation" of the ELISA results (positive, negative, equivocal) is inherent to the kit's design and predetermined cut-offs.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The primary ground truth used was pathology in the form of "biopsy with stain or culture results for H. pylori."
   • For cross-reactivity, ground truth for C. jejuni and C. fetus was established by "culture" (fecal culture on Campylobacter-specific media for C. jejuni, blood culture for C. fetus). For Borrelia burgdorferi, it was "positive for antibodies by ELISA and Western Blot."

7. The sample size for the training set:

   • The document does not mention a training set in the context of an algorithm or machine learning model. This is an ELISA kit, which is a biochemical assay with established protocols and reagents. Its "training" is more akin to assay development and optimization, rather than a data-driven machine learning training phase. The described studies are performance validation studies.

8. How the ground truth for the training set was established:

   • As there is no explicit training set in the context of an algorithm, this question is not applicable. The development and optimization of such a kit would rely on known positive and negative samples, but these are part of the assay development, not a "training set" with ground truth in the current sense of diagnostic AI.

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The Nichols Advantage® Chemiluminescence Helicobacter pylori IgG Antibodies Immunoassay is intended for use with the Nichols Advantage® Specialty System for the qualitative determination of anti-H. pylori IgG in human serum to aid in the diagnosis of infection by H. pylori.

The Nichols Advantage® Helicobacter pylori IgG Antibodies Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System. Nichols Institute Diagnostics utilizes chemiluminescence acridinium esters as the label in its specialty chemiluminescence system. Acridinium esters emit light upon treatment with hydrogen peroxide and an alkaline solution. The Trigger 1 solution contains hydrogen peroxide in diluted acid and Trigger 2 solution contains diluted sodium hydroxide. The system automatically injects Trigger solutions 1 and 2 into the wells of the cuvette which oxidize the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light, which is quantified in two seconds and is expressed in relative light units (RLU) by the integrated system luminometer. The Nichols Advantage® Anti-H. pylori IgG Assay is a two-site chemiluminescence immunoassay for the measurement of anti-H. pylori IgG in human serum. It utilizes an acridinium-ester-labeled mouse monoclonal anti-human IgG antibody and a biotinylated H. pylori antigen cocktail. The sample containing anti-H. pylori IgG antibodies is incubated with the biotinylated antigen cocktail and magnetic particles for 10 minutes at 37°C. Free, unbound biotinylated antigens and anti-H. pylori IgG antibodies are separated from the complex bound to the magnetic particles by aspiration of the reaction mixture and subsequent washing. Thereafter, acridinium-labeled anti-human IgG antibodies are added to the reaction mixture and a second 10 minute incubation follows creating the sandwich complex. Free, unbound acridinium-labeled anti-human IgG antibodies are separated from the complex bound to the magnetic particles by aspiration of the reaction mixture and subsequent washing. The wells containing the washed magnetic particles are transported into the system luminometer, which automatically injects Trigger 1 and Trigger 2, initiating the chemiluminescence reaction. The light is quantitated by the luminometer and expressed as RLU. The amount of bound-labeled antibody is directly proportional to the titer of anti-H. pylori IgG antibodies in the sample. The Nichols Advantage Specialty System automatically handles sample dilution as well as sample and reagent additions, the temperature-controlled incubation, separation/washing step, and measurement of the light output. It calculates test results for controls and patient samples from the stored calibration curve, and generates a printed report, which includes patient information.

Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for Nichols Advantage® H. pylori IgG Antibodies Immunoassay

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it presents performance characteristics and compares them to the predicate device, implying that the Nichols Advantage® assay's performance is considered acceptable if its characteristics are comparable or superior and meet the intended use.

Based on the "Performance Characteristics" section, here are the reported performance details:

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

The document does not explicitly state the sample size used for the "Method Comparison" test set, nor does it specify the country of origin of the data or whether the study was retrospective or prospective. It only presents the "Range of Results" for the method comparison as "1:13 to 1:5526" for the Nichols Advantage® assay and "1:97 to 1:9504" for the predicate device.

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

The document does not describe the use of experts to establish ground truth for the method comparison. The comparison is between the Nichols Advantage® assay and a predicate device (Orion Diagnostica Pyloriset® EIA-G Immunoassay), suggesting the predicate device's results served as a reference.

4. Adjudication Method for the Test Set

No adjudication method is described, as the comparison is primarily assay-to-assay.

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

No MRMC study was conducted or mentioned in the document. This is an in vitro diagnostic device, and MRMC studies are typically for imaging or interpretation tasks where human readers are involved.

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

The device itself is an automated immunoassay system. The performance characteristics described for the Nichols Advantage® system are inherently standalone (algorithm/device only) without human-in-the-loop performance influencing the assay's raw output. The system automatically handles processes and calculates results.

7. Type of Ground Truth Used

The ground truth for the method comparison study appears to be the results obtained from the predicate device, the Orion Diagnostica Pyloriset® EIA-G Immunoassay. The document states a "Method Comparison" was performed, and then provides "Concordance," "Percent Agreement Positive," and "Percent Agreement Negative" between the new device and the predicate. This implies the predicate's results were used as a reference for comparison.

8. Sample Size for the Training Set

The document describes an immunoassay, not a machine learning algorithm that typically has a "training set." Therefore, a "training set" in the context of data used to train an algorithm is not applicable here. The assay relies on established chemical and immunological principles, with performance validated through analytical and clinical studies.

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

As noted above, a "training set" for an algorithm is not applicable for this type of device. The assay's analytical performance (intra-assay, inter-assay, recovery, parallelism) would have been established using characterized samples with known concentrations/titer ranges, but this is part of analytical validation, not algorithm training.

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For the qualitative determination of IgG antibodies to Helicobactor pylori antigen in human sera by indirect enzyme immunoasay. The H.pylori IgG assay may be used as an aid in the diagnosis of H. pylori infection in adult patients with gastrointestinal symptoms. The test can be performed either manually or in conjunction with the MAGO® PLUS Automated EIA Processor.

The & H. pylori IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to H. pylori antigen in human serum.

This document describes the performance characteristics of the Is-H. pylori IgG ELISA Kit, an in vitro diagnostic (IVD) device used for the qualitative determination of IgG antibodies to Helicobacter pylori antigen in human sera.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the reported performance metrics, demonstrating the device's accuracy and precision.

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

• Sample Size for Sensitivity and Specificity Study (Section A): 249 patients.
  • 121 sera characterized as positive for H. pylori.
  • 128 sera characterized as negative for H. pylori.
• Sample Size for Relative Agreement Study (Section B): 249 patients (same samples as in Section A).
• Data Provenance: The sera were frozen retrospective samples from patients. The country of origin is not explicitly stated in the provided text.

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

The ground truth for characterizing H. pylori infection in the test set (Section A) was established using "biopsy with culture, stain and CLO results for H.pylori". While these are considered reference standard clinical tests, the document does not specify the number of experts (e.g., pathologists, microbiologists) who interpreted these results or their specific qualifications (e.g., years of experience as a pathologist). The interpretation of such tests inherently involves expert judgment, but the level of detail is not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (like 2+1 or 3+1) for resolving discrepancies in the biopsy, culture, stain, or CLO results that formed the ground truth. It states that "Based on the results of this testing, the patient sera were characterized." This implies that a consensus or a defined decision rule based on these multiple tests was used to establish the positive or negative status for each patient, but the specific adjudication process is not detailed. Equivocal results from the device under test were excluded from calculations, but this is a different kind of exclusion from an adjudication of ground truth.

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

No MRMC comparative effectiveness study was mentioned. This device is an immunoassay kit, not an AI-based image analysis or interpretation tool that would typically involve human readers and AI assistance for interpretation. Therefore, this section is not applicable.

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

For the sensitivity and specificity study (Section A), the device (Is-H. pylori IgG Test Kit) was tested on sera, and its results were compared to the biopsy-based ground truth. This represents standalone performance, as the interpretation of the ELISA results would be direct based on the established cut-off, without a human "reader" making a subjective judgment in the same way a radiologist reads an image.

The section on "Correlation of Manual and MAGO Plus Results" (Section D) and "MAGO Plus Precision" (Section E) studies the performance of the device when used with an automated EIA processor. This also represents standalone performance of the device in either manual or automated modes, where the device directly produces a result.

7. The Type of Ground Truth Used

The primary ground truth used for the sensitivity and specificity study (Section A) was based on biopsy with culture, stain, and CLO results for H. pylori. These are objective laboratory and histopathological methods considered gold standards for H. pylori infection diagnosis.

For the "Relative Agreement Versus Another ELISA" study (Section B), the "ground truth" was the results from "another commercially available kit for H. pylori IgG antibodies." However, the notice explicitly states: "Please be advised that 'relative' refers to the comparison of the assay's results to that of a similar assay. There was not an attempt to correlate the assay's results with disease presence or absence. No judgment can be made on the comparison's accuracy to predict disease." This clarifies that the predicate ELISA was used for relative performance comparison, not as a true gold standard for disease presence.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning. This device is an immunoassay kit (ELISA), which is a biochemical test, not an algorithm that requires a separate training set. The various studies described (Sensitivity/Specificity, Relative Agreement, Precision) are all validation studies for the device's performance.

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

As this is an immunoassay and not an AI/ML algorithm requiring a training set, this question is not applicable. The device itself produces a result based on a biochemical reaction and predefined interpretation rules.

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The Zeus Scientific, Inc., Helicobacter pylori IgG ELISA Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori in symptomatic adults 18 years or older. The test system is for in vitro diagnostic use.

enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to Helicobacter pylori

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about the acceptance criteria, study design, and results. The document is an FDA 510(k) clearance letter for a "Helicobacter pylori IgG ELISA Test System," which indicates that the device has been found substantially equivalent to a predicate device.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for test or training sets.
• Information on data provenance.
• The number or qualifications of experts used for ground truth.
• The adjudication method.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Results from a standalone performance study.
• The type of ground truth used.
• How ground truth was established for the training set.

This document is primarily concerned with the regulatory clearance of the device rather than the specific details of its validation study and performance metrics.

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The QUANTA Lite™ H. pylori IgG kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibodies to H. pylori (Helicobacter pylori) in patient sera. This test is intended to aid in the diagnosis of H. pylori infections in adult patients with clinical signs and symptoms of gastrointestinal disease. This test is for in vitro diagnostic use.

enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG antibodies to H. pylori (Helicobacter pylori) in patient sera.

The provided text is a 510(k) premarket notification letter from the FDA regarding the QUANTA Lite™ H. pylori IgG ELISA device. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment relevant to the device's accuracy or effectiveness study.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory approval based on substantial equivalence, not on the detailed performance characteristics and study design of the device itself.

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