Search Filters

Search Results

Found 4 results

510(k) Data Aggregation

    K Number
    K242706
    Device Name
    Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio
    Manufacturer
    Fujirebio Diagnostics, Inc.
    Date Cleared
    2025-05-16

    (249 days)

    Product Code
    SET
    Regulation Number
    866.5840
    Why did this record match?
    Search-Everything :

    Matched: '866.5840'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is an in vitro test using human plasma (K2EDTA) that combines the results of Lumipulse G pTau 217 Plasma and Lumipulse G β-Amyloid 1-42-N Plasma assays into a ratio of pTau 217 to β-Amyloid 1-42 concentrations using the LUMIPULSE G1200 System. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is intended to aid healthcare providers to identify patients with amyloid pathology associated with Alzheimer's disease. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is indicated for adult patients, aged 50 years and older, presenting at a specialized care setting with signs and symptoms of cognitive decline. A test result ≤ 0.00370 is a negative result which is consistent with patients who are unlikely to have amyloid pathology. These patients should be investigated for other causes of cognitive decline. A test result ≥ 0.00738 is a positive result which is consistent with patients who are likely to have amyloid pathology. This result does not establish a diagnosis of Alzheimer's disease or other cognitive disorders. A test result between 0.00371 and 0.00737 is an indeterminate result which is consistent with patients who are uncertain to have amyloid pathology. These patients should be considered for further testing. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio results must be interpreted in conjunction with other patient clinical information. This test is not intended as a screening or stand-alone diagnostic test.
    Device Description
    The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio is a test that combines the test results of the Lumipulse G pTau 217 Plasma assay and Lumipulse G β-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio from 0.00000 – 1.00000. The numerical ratio will be compared to the established cutoffs. Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio = Lumipulse G pTau 217 Plasma (results in pg/mL) / Lumipulse G β-Amyloid 1-42-N Plasma (results in pg/mL) = a numerical value targeted up to 1.00000. The Lumipulse G pTau 217 Plasma and Lumipulse G β-Amyloid 1-42-N Plasma are assay systems including a set of immunoassay reagents for the quantitative measurement of pTau 217 and β-amyloid1-42, respectively, in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology. The LUMIPULSE G1200 is an instrument platform that can perform automated chemiluminescence immunoassays of specimens using LUMIPULSE G reagents. The LUMIPULSE G1200 reports the results of the two individual assays separately, and the ratio calculation must be done manually by the operator.
    Ask a Question
    K Number
    K231348
    Device Name
    Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2023-06-05

    (27 days)

    Product Code
    QSE
    Regulation Number
    866.5840
    Why did this record match?
    Search-Everything :

    Matched: '866.5840'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elecsys ß-Amyloid (1-42) CSF II and Elecsys Total-Tau CSF are in vitro electrochemiluminescence immunoassays for the measurement of the ß-Amyloid (1-42) (Abeta42) and Total-Tau (tTau) concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a tTau/Abeta42 ratio value. A negative result, defined as tTau/Abeta42 ratio value below cut-off or an Abeta42 value above the measuring range, is consistent with a negative amyloid position emission tomography (PET) scan result. A negative result reduces the likelihood that a patient's cognitive impairment is due to AD. A postive result, defined as tTau/Abeta42 ratio value above cut-off, is consistent with a positive amyloid PET scan result does not establish a diagnosis of AD or other cognitive disorder. The tTau/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations. Limitations of Use The performance of the tTau/Abeta42 ratio has not been established for: · Predicting development of dementia or other neurologic conditions · Monitoring responses to therapies
    Device Description
    The Elecsys ß-Amyloid (1-42) II immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal β-Amyloid (1-42)-specific and monoclonal ß-Amyloid (1-42) antibodies labeled with a ruthenium complex. The Elecsys ß-Amyloid (1-42) II immunoassay is intended for the in vitro quantitative determination of ß-Amyloid (1-42) in human CSF. Similarly, the Elecsys Total-Tau immunoassay makes use of a two-step, double antigen sandwich principle using two biotinylated monoclonal Tau-specific antibodies (5.28.464 and 4.35.411) and a monoclonal Tau-specific (PC1P6) antibody labeled with a ruthenium complex. The Elecsys Total-Tau immunoassay is intended for the in vitro quantitative determination of Total-Tau in human CSF. The assays are indicated for use with adult subjects being evaluated for Alzheimer's disease and other causes of cognitive impairment. The results of the measurement of a CSF sample for each analyte in pg/mL is used in a ratio (tTau/Abeta42). The assays manually calculated ratio result is compared to a cutoff to determine if the test result indicates an amyloid PET positive or negative result. The result does not establish a diagnosis of AD or other cognitive disorders. Additionally, the result does not predict development of dementia or other neurologic disorders, nor does the result monitor responses to therapies. Both assays are intended for use on the cobas e 601 immunoassay analyzer. Results for each assay are determined by an analyte specific calibration curve generated by 2point calibration and a master curve provided via the reagent barcode or e-barcode.
    Ask a Question
    K Number
    K221842
    Device Name
    Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF
    Manufacturer
    Roche Diagnostics
    Date Cleared
    2022-12-07

    (166 days)

    Product Code
    QSE
    Regulation Number
    866.5840
    Why did this record match?
    Search-Everything :

    Matched: '866.5840'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Elecsys ß-Amyloid (1-42) CSF II and Elecsys Phospho-Tau (181P) CSF are in vitro electrochemiluminescence immunoassays for the measurement of the ß-Amyloid (1-42) (Abeta42) and Phospho-Tau (181P) (pTau181) protein concentrations in cerebrospinal fluid (CSF) from adult patients aged 55 years and older being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment to generate a pTau181/Abeta42 ratio value. A negative result, defined as pTaul 81/Abeta42 ratio value below cut-off or an Abeta42 value above the measuring range. is consistent with a negative amyloid position tomography (PET) scan result. A negative result reduces the likelihood that a patient's cognitive impairment is due to AD. A positive result, defined as pTaul 81/Abeta42 ratio value above cut-off, is consistent with a positive amyloid PET scan result does not establish a diagnosis of AD or other cognitive disorder. The pTaul 81/Abeta42 ratio result is used as an adjunct to other clinical diagnostic evaluations.
    Device Description
    The Elecsys ß-Amyloid (1-42) II immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal β-Amyloid (1-42)-specific and monoclonal ß-Amyloid (1-42) antibodies labeled with a ruthenium complex. The Elecsys ß-Amyloid (1-42) II immunoassay is intended for the in vitro quantitative determination of ß-Amyloid (1-42) (Abeta42) in human CSF. Similarly, the Elecsys Phospho-Tau (181P) immunoassay makes use of a two-step, double antigen sandwich principle using a biotinylated monoclonal Phospho-Tau (181P)-specific and monoclonal Phospho-Tau (181P) antibodies labeled with a ruthenium complex. The Elecsys Phospho-Tau (181P) immunoassay is intended for the in vitro quantitative determination of Phospho-Tau (181P) (pTau181) in human CSF. The assays are indicated for use with adult subjects being evaluated for Alzheimer's disease and other causes of cognitive impairment. The results of the measurement of a CSF sample for each analyte in pg/mL is used in a ratio (pTau181/Abeta42). The assays manually calculated ratio result is compared to a cutoff to determine if the test result indicates an amyloid PET positive or negative result. The result does not establish a diagnosis of AD or other cognitive disorders. Additionally, the result does not predict development of dementia or other neurologic disorders, nor does the result monitor responses to therapies. Both assays are intended for use on the cobas e 601immunoassay analyzer. Results for each assay are determined by an analyte specific calibration curve generated by 2point calibration and a master curve provided via the reagent barcode or e-barcode.
    Ask a Question
    K Number
    DEN200072
    Device Name
    Lumipulse G ß-Amyloid Ratio (1-42/1-40)
    Manufacturer
    Fujirebio Diagnostics, Inc.
    Date Cleared
    2022-05-04

    (530 days)

    Product Code
    QSE, OSE
    Regulation Number
    866.5840
    Why did this record match?
    Search-Everything :

    Matched: '866.5840'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Lumipulse G B-Amyloid Ratio (1-42/1-40) is an in vitro cerebral spinal fluid (CSF) test that combines the results of Lumipulse G B-Amyloid 1-42 and Lumipulse & B-Amyloid 1-40 assays into a ratio of ß-amyloid 1-42 to ß-amyloid 1-40 concentrations using the LUMIPULSE G 1200 System. The Lumipulse G B-Amyloid Ratio (1-42/1-40) is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. A test result ≥ 0.073 is a negative result which is consistent with a negative amyloid positron emission tomography (PET) scan result. A negative result reduces the likelihood that a patient's cognitive impairment is due to AD. A test result ≤ 0.058 is a positive result which is consistent with a positive amyloid PET scan result. A positive result does not establish a diagnosis of AD or other cognitive disorder. A test result between 0.059 and 0.072 is considered as a likely positive result as it is more likely consistent with a positive amyloid PET scan result. A likely positive result does not establish a diagnosis of AD or other cognitive disorders and has increased uncertainty in regard to amyloid PET positivity. The Lumipulse G B-Amyloid Ratio (1-42/1-40) results must be interpreted in conjunction with other patient clinical information . This test is not intended as a screening or stand-alone diagnostic test.
    Device Description
    The Lumipulse G B-Amyloid Ratio (1-42/1-40) is an in vitro cerebral spinal fluid (CSF) test that calculates the ratio of two analytes, Lumipulse G ß-Amyloid 1-42 and Lumipulse & ß-Amyloid 1-40 assays to generate a numeric value between 0.001 to 1.000. The test system consists of two component assays, Lumipulse & ß-Amyloid 1-42 and the Lumipulse G B-Amyloid 1-40 assay, running on LUMIPULSE G1200 system, and Lumipulse G B-Amyloid Ratio (1-42/1-40) Calculator Tool to calculate the Lumipulse G B-Amyloid Ratio (1-42/1-40). Lumipulse G B-Amyloid 1-42 and the Lumipulse G B-Amyloid 1-40 assays are packed individually. Results of individual assays have not been assessed to support the intended use except for determination of the Lumipulse G ß-Amyloid Ratio (1-42/1-40).
    Ask a Question

    Page 1 of 1