(73 days)
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Pharmacia CAP System RAST® FEIA, AlaSTAT Microplate Allergen-Specific IgE, AlaSTAT EIA Allergen-Specific IgE
No
The description focuses on standard immunoenzymometric assay technology and does not mention any AI or ML components.
No.
The device is strictly for in vitro diagnosis of IgE-mediated allergic disorders, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended strictly for in vitro diagnosis of IgE-mediated allergic disorders."
No
The device description clearly indicates it is a liquid-phase immunoenzymometric assay in microplate and tube formats, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "They are intended strictly for in vitro diagnosis of IgE-mediated allergic disorders." The term "in vitro diagnosis" is the defining characteristic of an IVD.
- Device Description: The description details a "liquid-phase immunoenzymometric assays" for detecting antibodies in "circulating allergen-specific IgE antibodies." This describes a laboratory test performed on biological samples (blood in this case, as it's detecting circulating antibodies) outside of the living organism, which is consistent with an in vitro diagnostic.
- Performance Studies: The mention of "clinical performance... compared to one of the following A compressional de l'autorial de l'artists of patient samples" further indicates that the device is used to analyze patient samples for diagnostic purposes.
- Predicate Devices: The listed predicate devices, such as "Pharmacia CAP System RAST® FEIA," are well-known IVD allergy testing systems. This suggests the device falls within the same category.
The core function of the device is to analyze biological samples (blood) to provide diagnostic information about a patient's health (IgE-mediated allergic disorders), which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The 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 following: Pharmacia CAP System RAST® FEIA, AlaSTAT Microplate Allergen-Specific IgE, or AlaSTAT EIA Allergen-Specific IgE. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Pharmacia CAP System RAST® FEIA, AlaSTAT Microplate Allergen-Specific IgE, AlaSTAT EIA Allergen-Specific IgE
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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.
1
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