(73 days)
DPC's AlaSTAT Microplate and AlaSTAT EIA specific allergen modules and mixed allergen panels are intended for use with the AlaSTAT Microplate and AlaSTAT EIA Allergen-Specific IgE systems in measuring allergen-specific circulating levels of specific IgE. They are intended strictly for in vitro diagnosis of IgE-mediated allergic disorders.
The AlaSTAT® Microplate and AlaSTAT® EIA Allergen-Specific IgE allergy tests are liquid-phase immunoenzymometric assays in microplate and tube formats respectively for the detection of circulating allergen-specific IgE antibodies. The specific allergens are covalently attached to a soluble polymer/copolymer matrix, thus permitting optimum presentation of the determinants to circulating IgE antibodies. The Specific Allergen Modules and Mixed Allergen Panels for the AlaSTAT® Microplate and AlaSTAT® EIA Allergen-Specific IgE systems are run in the same manner as all other AlaSTAT® Microplate and AlaSTAT® EIA Allergen-Specific IgE tests. Test results are given in kilo-Units per liter (kU/L) for AlaSTAT® Microplate and International Units per milliliter (IU/mL) for AlaSTAT® EIA, as well as a Class number for both formats.
This document describes the AlaSTAT Microplate and AlaSTAT EIA Allergen-Specific IgE systems, specifically focusing on the performance equivalence of additional Specific Allergen Modules and Mixed Allergen Panels.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or correlation coefficients). Instead, it relies on a qualitative statement of "performance equivalence."
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to legally marketed devices (Pharmacia CAP System RAST® FEIA, existing AlaSTAT Microplate Allergen-Specific IgE, existing AlaSTAT EIA Allergen-Specific IgE) | Clinical performance of the AlaSTAT Microplate and AlaSTAT EIA Allergen-Specific IgE Systems methods for each of the 63 allergens were compared to one of the predicate devices using "a compressional de l'autorial de l'artists of patient samples." The results "support the conclusion that the device is as safe and effective, and performs as well as or better than the other legally marketed devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "a compressional de l'autorial de l'artists of patient samples," which is vague and does not provide a specific sample size. "Compressional de l'autorial de l'artists" appears to be a typo or OCR error and does not convey a meaningful quantity.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. The study is a method comparison study against predicate devices, not a study where human experts established a ground truth for a test set. The "ground truth" here is effectively the results obtained from the predicate devices.
4. Adjudication Method for the Test Set:
- Not Applicable. As it's a method comparison, there was no adjudication process in the sense of resolving discrepancies between multiple human readers or annotators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No. This was not an MRMC study. It was a comparison of device performance against other devices, not a study assessing the improvement of human readers with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, implicitly. The comparison described is between the new AlaSTAT modules/panels and the predicate devices. This represents the standalone performance of the assay itself, as there's no mention of human intervention in interpreting the raw assay results that are then compared.
7. The Type of Ground Truth Used:
- Comparative Reference Standard / Predicate Device Results. The "ground truth" for this study was the results obtained from established, legally marketed allergen-specific IgE assays (Pharmacia CAP System RAST® FEIA, existing AlaSTAT Microplate, and AlaSTAT EIA systems). The study aimed to show equivalence to these existing methods.
8. The Sample Size for the Training Set:
- Not Applicable / Not Mentioned. This document describes a performance evaluation of a diagnostic test kit, not a machine learning algorithm that requires a training set in the typical sense. The "training" for such a device involves assay development, reagent optimization, and calibration, not a data-driven training set.
9. How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Mentioned. As noted above, this type of device does not typically have a "training set" with established ground truth in the way a machine learning model does.
In summary:
The provided document describes a method comparison study to demonstrate "performance equivalence" of new allergen modules/panels for existing AlaSTAT IgE detection systems against predicate devices. It lacks specific quantitative acceptance criteria and detailed information on sample size, data provenance, or the involvement of human experts for ground truth establishment. The "ground truth" was established by the predicate devices themselves.
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annostic Products Cornoration
OCT 10 1996
Intended Use of the Devices:
DPC's AlaSTAT Microplate and AlaSTAT EIA specific allergen modules and mixed allergen panels are intended for use with the AlaSTAT Microplate and AlaSTAT EIA Allergen-Specific IgE systems in measuring allergen-specific circulating levels of specific IgE. They are intended strictly for in vitro diagnosis of IgE-mediated allergic disorders.
Summary and Explanation of the test:
Many allergies are mediated by immunoglobulins of the IgE class. In sensitized individuals suffering from this immediate (atopic or anaphylactic) type of allergy, IgE molecules act as points of contact between the allergen and specialized cells that release histamine and other agents upon exposure to the allergen; this initiates the events which we recognize as allergic reactions. When evaluated in the light of other clinical and laboratory findings, in vitro allergen-specific IgE tests can help the physician identify the allergen (or allergens) to which an individual is sensitive.
Technological Comparison to Predicate:
The AlaSTAT® Microplate and AlaSTAT® EIA Allergen-Specific IgE allergy tests are liquid-phase immunoenzymometric assays in microplate and tube formats respectively for the detection of circulating The specific allergens are covalently attached to a soluble allergen-specific IgE antibodies. polymer/copolymer matrix, thus permitting optimum presentation of the determinants to circulating IgE antibodies. The Specific Allergen Modules and Mixed Allergen Panels for the AlaSTAT® Microplate and AlaSTAT® EIA Allergen-Specific IgE systems are run in the same manner as all other AlaSTAT® Microplate and AlaSTAT® EIA Allergen-Specific IgE tests. Test results are given in kilo-Units per liter (kU/L) for AlaSTAT® Microplate and International Units per milliliter (IU/mL) for AlaSTAT® EIA, as well as a Class number for both formats
The Pharmacia CAP System RAST® FEIA is an in vitro test system, based on ImmunoCAP technology for determination of circulating specific IgE antibodies. The allergen of interest, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient serum specimen. To classify test results, fluorescence (FU) for patient samples are compared directly with FU for standards run in parallel. Test results are given in either kilo-Units per Liter (kU/L) or in Alternative Scoring Method (ASM) classes.
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Diagnostic Products Corporation On West 96th Street naeles. CA 90045
Performance Equivalence-Method Comparison:
The clinical performance of the AlaSTAT Microplate and AlaSTAT EIA Allergen-Specific IgE Systems methods for each of the 63 allergens on were compared to one of the following A compressional de l'autorial de l'artists of patient samples, with results that support the conclusion that the device is as safe and effective, and performs as well as or better than the other legally marketed devices identified below.
- · Pharmacia CAP System RAST® FEIA
- · AlaSTAT Microplate Allergen-Specific IgE
- ·AlaSTAT EIA Allergen-Specific IgE
Performance Equivalence:
Diagnostic Products Corporation (DPC) asserts that the AlaSTAT® Microplate and AlaSTAT® EIA Allergen-Specific IgE systems produce substantially equivalent IgE results to other commercially marketed allergen-specific IgE assays. Each product is intended strictly for in vitro diagnostic use to aid in the clinical diagnosis of IgE-mediated allergic disorders.
Conclusion:
The information presented in this summary of safety and effectiveness is the information that the Food and Drug Administration used in granting DPC substantial equivalence for the additional Specific Allergen Modules and Mixed Allergen Panels for AlaSTAT Microplate and AlaSTAT EIA Allergen-Specific IgE Systems.
Edward h heier
Edward M. Levine, Ph.D. Manager of Clinical Affairs
5/15/96
Date
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).