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The HY • TEC™ Specific and Total IgE EIA System is an enzyme immunoassay (EIA) method for the quantitative determination of allergen-specific and/or total IgE concentrations in human serum. The assay is to be used with the HY . TECTM 288 instrument for in-vitro diagnostic use. Measurement of specific allergen antibodies and total IgE may aid in the diagnosis of asthma, allergies and other pulmonary disorders.

The HY . TEC 288 Automated EIA instrument is a fully-automated system, which performs sample dilution and pipetting, incubation, washing, reading and data analysis and prints reports. The new modified MCS (Modified Classification System) Specific/Total IgE assay includes the current set of five calibrators (100, 17.5, 3.5, 0.70 and 0.35 IU/mL) and a new zero calibrator.

The HY . TEC allergy system is standardized using anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502 and offers a broad menu of specific allergens. The HY · TEC reagents have been optimized to provide a fast, sensitive sandwich immunoassay with a dynamic range from 0.05 to 100 IU/mL. An allergen-coated paper disc is incubated with a serum sample. Non-specific proteins are removed by washing and the disc is incubated with enzyme-labeled monoclonal anti human IgE conjugate. Following a second wash, substrate color is developed. The results are read spectrophotometrically against a calibration curve; results are reported in both IU/mL and Classes. The HY . TEC MCS Specific/Total IgE assay requires only three hours of total incubation time and completes assay runs within six hours for the maximum assay size of 288 tests.

The provided document is a 510(k) summary for the HY.TEC™ Automated EIA System for Total IgE and Specific IgE. It describes the device and its intended use, and states that it is substantially equivalent to a previously cleared device. However, it does not include a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert involvement as requested.

The document states: "Assay performance, including correlation with the predicate, analytical sensitivity, limit of detection, intra and inter assay precision, and dilution linearity demonstrate the acceptability of the zero calibrator." This sentence broadly mentions performance aspects but does not provide the acceptance criteria or reported performance values.

Therefore, I cannot populate the table or answer the specific questions about the study design in detail based solely on the provided text.

Here's an assessment based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample size for test set: Not specified in the provided document.
• Data provenance (country of origin, retrospective/prospective): Not specified in the provided document.

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

• This device is an in-vitro diagnostic system for laboratory use. The "ground truth" in this context would typically be established through reference methods or clinical diagnosis, not by experts adjudicating images or cases in the way described for AI/imaging devices. No information on experts or their qualifications is provided, as it's not directly relevant to this type of device's validation as presented.

4. Adjudication method for the test set:

• Not applicable as this is an in-vitro diagnostic device and its performance is typically assessed through analytical validation (e.g., measuring known concentrations, comparing to a predicate device). No adjudication method for a "test set" is described.

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. This is an in-vitro diagnostic system, not an AI or imaging device involving human readers or interpretation of complex cases. Therefore, an MRMC study or AI-assistance effect size is not applicable and not mentioned.

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

• The device described is an "Automated EIA System." Its inherent function is standalone (without human intervention once initiated) for sample processing, dilution, incubation, washing, reading, and data analysis. However, "standalone" in the context of AI performance studies usually refers to an AI algorithm's performance without a human in the diagnostic loop. This document doesn't describe AI or machine learning algorithms; it describes an automated laboratory instrument with chemical reactions. The performance validation would be on the instrument's analytical capabilities, which is inherently "standalone" in its operation.

7. The type of ground truth used:

• For an in-vitro diagnostic device like this, ground truth ("truth") is established by:
  • Referenced Calibrators/Standards: The device is standardized using "anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502." This serves as a primary form of ground truth for calibrating the system.
  • Comparison to predicate device: The document mentions "correlation with the predicate" as part of the assay performance evaluation, implying the predicate device's results serve as a comparative standard.
  • Known concentrations/samples: Analytical sensitivity, limit of detection, precision, and linearity studies usually involve testing samples with known concentrations of the analyte.

8. The sample size for the training set:

• Not applicable. This device is an automated instrument for performing immunoassays, not an AI model that requires a "training set" in the machine learning sense. The "training" would refer to calibrating the instrument using reference materials (as mentioned in point 7).

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

• As above, not applicable in the typical machine learning sense. The instrument is calibrated using reference sera calibrated against WHO 2nd IRP 75/502. This international standard establishes the "ground truth" for the calibrators used by the system.

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The HY . TECTM Extended Specific IgE EIA, MCS Assay Using The Tecan Freedom EVO® RSP 200 is an enzyme immunoassay (EIA) method for the quantitative determination of allergen-specific IgE concentrations in human serum. The assay system is for in-vitro diagnostic use. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.

The EVO RSP 200 Automated EIA instrument is a fully-automated system, which performs sample dilution and pipetting, incubation, washing, reading and data analysis and prints reports. The EVO RSP 200 Automated EIA System for Specific IgE performs the same functions as the HY . TEC 480 Automated EIA System. The specific IgE assay for both systems, the HY .TEC 480 and the EVO RSP 200, is the same (utilizes same reagents and procedures) except for the following: A zero calibrator is being added to the current set of five calibrators (0.35, 0.7, 3.5, 17.5 and 100 IU/mL) for the EVO Specific IgE assay. The incubation times and temperatures have been changed. The HY . TEC 480 and EVO RSP 200 allergy systems are standardized using anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502 and offers a broad menu of specific allergens. An allergen-coated paper disc is incubated with a serum sample. Non-specific proteins are removed by washing and the disc is incubated with enzyme-labeled monoclonal anti human IgE conjugate. Following a second wash, substrate color is developed. The results are read spectrophotometrically against a calibration curve; results are reported in both IU/mL and Classes.

The provided text describes a 510(k) submission for a medical device called "The HY•TEC™ Extended Specific IgE EIA, MCS Assay Using The Tecan Freedom EVO® RSP 200". This document focuses on demonstrating substantial equivalence to a predicate device and outlines the intended use and a brief comparison.

Unfortunately, the input document does not provide explicit acceptance criteria or detailed results of a study to demonstrate the device meets these criteria. Instead, it states that "Validation of software, instrument functions and assay performance, including correlation with the predicate, intra and inter assay precision, limits of detection and quantitation, and dilution linearity demonstrate the acceptability of the EVO RSP 200." However, it does not present the specific acceptance thresholds for these performance metrics or the actual reported values.

Therefore, I cannot populate most of the requested sections accurately based on the provided text. I will address the points that can be inferred or explicitly stated.

Acceptance Criteria and Study Details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that these metrics were validated and demonstrated acceptability, but it does not specify the quantitative acceptance criteria or the actual performance values obtained.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "validation of software, instrument functions and assay performance."

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

This information is not provided in the document. The type of device (an in-vitro diagnostic system for quantitative determination of allergen-specific IgE) typically relies on analytical performance studies rather than expert-derived ground truth from images or clinical assessments in the way, for example, a radiology AI would.

4. Adjudication Method for the Test Set

This is not applicable and not provided as the device is an in-vitro diagnostic assay, not a system requiring human expert adjudication for its primary performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices where human readers interpret results, often with and without AI assistance. This device is an in-vitro diagnostic instrument for quantitative measurement of IgE.

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

This device is an in-vitro diagnostic instrument, not an algorithm that operates standalone in a clinical context. Its "standalone" performance would be its analytical performance (precision, accuracy, LoD, LoQ, linearity), which were generally stated to have been validated, but specific study details are not provided. The device itself is "fully-automated" for its specified functions.

7. The Type of Ground Truth Used

For this type of in-vitro diagnostic device, the "ground truth" for analytical performance studies would typically be established through:

• Reference materials/standards: Calibrators (e.g., WHO 2nd IRP 75/502) and controls with known IgE concentrations.
• Comparison to a gold standard method or predicate device: As indicated by "correlation with the predicate" in the document.

The document mentions that the system is "standardized using anti-IgE discs and reference sera calibrated against WHO 2nd IRP 75/502." This suggests the basis for quantitative accuracy.

8. The Sample Size for the Training Set

The document does not provide any information regarding a "training set" or its sample size. This is consistent with an in-vitro diagnostic assay validation rather than a machine learning model development.

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

This is not applicable as the document does not describe a training set in the context of machine learning. The device's "training" in a broad sense would relate to its calibration and standardization, as mentioned with the WHO reference standard.

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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgM autoantibodies to ß-2 Glycoprotein-I (ß-2 GPI) antibodies in human serum
Uses:
The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-ß-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.
This device can be used with the HYCOR HY.TEC automated EIA instrument.
For in vitro diagnostic use only.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device called "Autostat™II Anti-ß2 Glycoprotein -I IgM ELISA." This document grants market clearance based on substantial equivalence to a predicate device, rather than providing a detailed study report demonstrating device performance against specific acceptance criteria.

Therefore, the information required to answer the prompt (acceptance criteria, study details, expert qualifications, etc.) is not present in the provided text. The letter primarily focuses on the regulatory aspects of device clearance.

To answer the prompt, I would need access to the actual 510(k) submission or a detailed study report for the "Autostat™II Anti-ß2 Glycoprotein -I IgM ELISA" device.

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Enzyme linked immunosorbent assay method for the semi-quantitative determination of specific IgG autoantibodies to ß2-Glycoprotein I (ß2-GPI) antibodies in human serum.

Uses:

The results of the anti- ß -2 GPI assay can be used as an aid in the diagnosis of auto-immune diseases associated with elevated levels of anti-B-2 GPI antibodies including antiphospholipid syndrome. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime.

This device can be used with the HYCOR HY•TEC automated EIA instrument.

For in vitro diagnostic use only.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a diagnostic device called Autostat™I Anti-ß2 Glycoprotein -IgG ELISA. This letter primarily focuses on the FDA's decision regarding the substantial equivalence of the device to a legally marketed predicate device, rather than providing a detailed study report with acceptance criteria and device performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided text.

This document confirms the device's clearance for marketing, states its intended use as an aid in diagnosing autoimmune diseases associated with elevated anti-ß2 GPI antibodies, and specifies that it is for in vitro diagnostic use only. It also mentions that the device can be used with the HYCOR HY•TEC automated EIA instrument. However, it does not include the technical study data that would typically contain the requested information.

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These assays (RIA&EIA) are to be used to detect antibodies (IgE) in a single serum specimen. The results of the latex assay can be used as an aid in diagnosis of allergy to latex.

Not Found

The provided text is related to a 510(k) premarket notification for a medical device called "HYCOR Allergen Disc (K82)", which is used to detect IgE antibodies to Hevea braziliensis (Latex) as an aid in diagnosing latex allergy.

However, the provided document is a clearance letter from the FDA and does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in your bullet points (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details).

This document simply states that the FDA has reviewed the 510(k) and found the device to be substantially equivalent to legally marketed predicate devices, thus allowing it to be marketed. The technical performance data, including acceptance criteria and study details, would have been part of the original 510(k) submission, which is not provided here.

Therefore, I cannot extract the requested information from the given text.

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