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Found 67 results
510(k) Data Aggregation
K Number
K242531Device Name
NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay Analyz
Manufacturer
Hycor Biomedical
Date Cleared
2025-04-23
(240 days)
Product Code
DHB
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
Device Description
The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti‐human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin‐coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen‐specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.
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K Number
K212181Device Name
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
Manufacturer
Phadia AB
Date Cleared
2022-08-03
(386 days)
Product Code
DHB
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Specific IgE is to be used with the instruments Phadia 1000, Phadia 2500 and Phadia 5000.
Device Description
ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.
Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000 instrument systems, and associated software, processes all steps of the assay and calculates results automatically after the assay is completed. Analytical and clinical validation of these components were performed on the representative instrument Phadia 250 and Phadia 1000.
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K Number
K220162Device Name
Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria
Manufacturer
Hycor Biomedical
Date Cleared
2022-02-18
(29 days)
Product Code
DHB
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
Device Description
The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin-coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.
The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.
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K Number
K193613Device Name
Allergen-Specific IgE Assay 12 Allergen Bundle
Manufacturer
Hitachi Chemical Diagnostics, Inc.
Date Cleared
2021-10-18
(662 days)
Product Code
DHB
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OPTIGEN® Allergen-Specific IgE Assay 12 Allergen Bundle A is an in vitro test for use in the semi-quantitative determination of circulating allergen specific IgE concentrations in human serum. OPTIGEN® Allergen-Specific IgE assays are meant to be included in panel tests to be used with the AP3600™ instrument. Each assay is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergenic disorders in conjunction with other clinical findings and are to be used in clinical laboratories.
The OPTIGEN® 12 Allergen Bundle A includes Almond (f20), Bermuda Grass (g2), Cashew (f207), Crab (f23), Hazelnut (Food) (f17), Oak, White (f7), Salmon (f41), Sesame Seed (f10), Shrimp (f24), Tuna (f40), and Walnut (Food) (f256).
Device Description
Not Found
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K Number
K200825Device Name
NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratense
Manufacturer
Hycor Biomedical
Date Cleared
2020-06-26
(88 days)
Product Code
DHB
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
Device Description
The NOVEOS Specific IgE Assay is an immunometric, chemilyminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample. The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IqE) 11/234.
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K Number
K200279Device Name
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine
Manufacturer
Phadia AB
Date Cleared
2020-05-01
(87 days)
Product Code
DHB
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine, is intended for in vitro diagnostic use, in human serum or EDTA plasma, as an aid in the diagnosis of IgE mediated mammalian (red) meat hypersensitivity, due to alpha-Gal sensitization, and to be used in conjunction with other clinical findings. This test is not to be the sole criterion for diagnosing allergy to alpha-Gal. It is a quantitative test to be used in clinical laboratories. ImmunoCAP Allergen 0215, alpha-Gal is to be used with the ImmunoCAP Specific IgE assay on the instrument Phadia™ 250.
Device Description
ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine, is a component of, and is designed to be used with, the ImmunoCAP Specific IgE assay, previously cleared under K051218. The test has the same overall design as all other ImmunoCAP Allergen components and uses identical assay and system specific reagents, instruments and software.
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K Number
K191510Device Name
Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae
Manufacturer
Hycor Biomedical
Date Cleared
2019-07-31
(55 days)
Product Code
DHB
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
Device Description
The NOVEOS™ Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.
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K Number
K190315Device Name
ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat
Manufacturer
Phadia AB
Date Cleared
2019-05-14
(90 days)
Product Code
DHB
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ImmunoCAP Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Specific IgE is to be used with the instrument Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
Device Description
ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.
Phadia 100, Phadia 250, Phadia 2500 and Phadia 5000 instrument systems, associated software, processes all steps of the assay and calculates results and a automatically after the assay is completed.
The allergen of interest, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient sample. After washing away non-specific IgE, enzyme labeled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgE is present in the specimen. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.
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K Number
K182793Device Name
AP3600 Automated Instrument
Manufacturer
Hitachi Chemical Diagnostics, Inc.
Date Cleared
2019-03-19
(169 days)
Product Code
DHB
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AP 3600 Automated Instrument, in conjunction with the OPTIGEN Allergen-Specific IgE Assay, is for the semiquantitative measurement of circulating allergen-specific IgE antibodies in human serum. The OPTIGEN Allergen-Specific IgE Assay is intended to aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings. The AP 3600 Automated Instrument is a software-enabled instrument designed for use with the OPTIGEN Allergen-Specific IgE Assay in clinical laboratories for sample processing, measurement analyses, and reporting of OPTIGEN Allergen-Specific IgE Assay results.
Device Description
The AP 3600 Automated Instrument is a software-enabled instrument designed for use with the OPTIGEN Allergen-Specific IgE Assay in clinical laboratories for sample processing, measurement analyses, and reporting of OPTIGEN Allergen-Specific IgE Assay results.
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K Number
K182479Device Name
NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus
Manufacturer
Hycor Biomedical
Date Cleared
2018-12-04
(85 days)
Product Code
DHB, JJE
Regulation Number
866.5750Why did this record match?
Product Code :
DHB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NOVEOS™ Immunoassay Analyzer: The NOVEOS™ Immunoassay Analyzer is an automated chemiluminescent immunoassay analyzer for measurement of analyte concentration in human specimens. It is intended for in vitro diagnostic use in the clinical laboratory.
NOVEOS™ Specific IgE (sIgE) Assay: The NOVEOS™ Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS™ Specific IgE Assay is to be used with the NOVEOS™ Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
Device Description
The NOVEOS™ Immunoassay Analyzer is a high-throughput, highly automated immunoassay platform that employs magnetic microbeads as the solid phase. The immunoassay reaction takes place in individual reaction chambers in the reaction rotor, with other rotors containing patient samples and reagents. Liquids are moved by robotic pipettors. The reaction is quantitated by a combination of chemiluminescence and fluorescence measurements compared to a calibration curve, all performed by the analyzer with the NOVEOS software.
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