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510(k) Data Aggregation
(136 days)
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(222 days)
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(137 days)
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.
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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(80 days)
The Diazyme Human Kappa (κ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.
The Diazyme Human Lambda (λ) Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple myeloma and aids in the evaluation of monoclonal gammopathy of undetermined significance (MGUS) in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.
No modification is made to the kit components for the Diazyme Human Kappa (κ) and Lambda (λ) Free Light Chain Assays cleared in K153394.
The Diazyme Human Kappa (κ) Free Light Chain Assay is comprised of the following reagents:
- Reagent R1: Tris buffer solution
- Reagent R2: Carboxyl Polystyrene particles coated with polyclonal rabbit and goat anti-Kappa FLC antibodies
- Calibrators: A five-level set in liquid form (5 x 1 mL)
Material required but not provided
- Controls Set: Two levels, serum based, liquid form
The Diazyme Human Lambda (λ) Free Light Chain Assay is comprised of the following reagents:
- Reagent R1: Tris buffer solution
- Reagent R2: Carboxyl Polystyrene particles coated with polyclonal rabbit anti-Lambda FLC antibodies
- Calibrators: A five-level set in liquid form (5 x 1 mL)
Material required but not provided
- Controls Set: Two levels, serum based, liquid form
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(264 days)
The ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA) assay is for in vitro diagnostic use in the quantitative measurement of cytokeratin 19 fragments in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XPT system.
The measurement of cytokeratin 19 is used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical information used for monitoring lung cancer.
The ADVIA Centaur Cytokeratin Fragment 21-1 assay includes 1 ReadyPack primary reagent pack containing ADVIA Centaur CYFRA Lite Reagent and Solid Phase and ADVIA Centaur CYFRA master curve card.
The ReadyPack consists of the following:
ADVIA Centaur Cytokeratin Fragment 21-1 ReadyPack primary reagent pack; Liquid Lite Reagent 10.0 mL/reagent pack KS19.1 monoclonal antibody acridinium conjugate in buffer containing bovine serum albumin; surfactant; and preservatives.
ADVIA Centaur Cytokeratin Fragment 21-1 ReadyPack primary reagent pack; Liquid Solid Phase Reagent 17.5 mL/reagent pack BM19.21 monoclonal antibody coupled to magnetic microparticle bead in buffer containing bovine serum albumin; surfactant; and preservatives.
ADVIA Centaur Multi-Diluent13 ReadyPack ancillary reagent pack; 2×10.0mL/reagent pack; Buffer; surfactant; sodium azide (< 0.1%)
This assay is a fully automated 1-step sandwich immunoassay using acridinium ester chemiluminescent technology. The Solid Phase contains magnetic microparticles coated with anti-CYFRA 21-1 BM19.21 mouse monoclonal antibody. The Lite Reagent consists of acridinium ester-labeled anti-CYFRA 21-1 KS19.1 mouse monoclonal antibody. A direct relationship exists between the amount of CYFRA 21-1 present in the patient sample and the amount of relative light units (RLUs) detected by the system.
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(261 days)
The ADVIA Centaur Anti-Thyroglobulin II (aTgII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroglobulin in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur XP system.
Anti-thyroglobulin (aTg) measurements are used, in conjunction with clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis and Graves' disease.
| Component | Volume | Ingredients |
|---|---|---|
| ADVIA Centaur aTgII Primary Reagent ReadyPack (included in assay kit) | ||
| ADVIA Centaur aTgII Lite Reagent | 10.0 mL/pack | Human thyroglobulin labeled with acridinium ester (~1.2 µg/mL); buffered saline; bovine gamma globulin; |
| ADVIA Centaur aTgII Solid Phase Reagent | 20.0 mL/pack | Biotinylated human thyroglobulin bound to streptavidin-coated paramagnetic particles (~0.6 mg/mL); buffered saline; bovine gamma globulin; BSA; sodium azide (< 0.1%); preservative |
| ADVIA Centaur aTgII Ancillary Reagent ReadyPack (included in assay kit) | ||
| ADVIA Centaur aTgII Ancillary Reagent | 17.5 mL/pack | Goat serum; mouse serum; sodium azide (< 0.1%); preservative |
| ADVIA Centaur aTgII Calibrator (included in assay kit) | ||
| ADVIA Centaur aTgII Low and High Calibrators | 1.0 mL/vial Lyophilized | After reconstitution, low or high levels of monoclonal mouse anti-human thyroglobulin; goat serum; mouse serum; sodium azide (< 0.1%); preservative |
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(231 days)
The Alegria Flash CTD Screen kit is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to SSA-60, SSA-52, SS-B, Jo-1, Scl-70, SmRNP, Sm, dsDNA, Ribosomal P, Nucleosome, and Centromere-B in human serum. The presence of these autoantibodies is intended for use as an aid in the diagnosis of the connective tissue diseases (CTD): Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), systemic sclerosis (SSc), mixed connective tissue disease (MCTD), Limited Cutaneous Systemic Sclerosis (CREST Syndrome), polymyositis, and dermatomyositis along with other laboratory and clinical findings. The test must be performed on the Alegria Flash instrument.
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(269 days)
Immunoglobulin Isotypes (GAM) for the EXENT Analyser:
The Immunoglobulin Isotypes (GAM) for the EXENT Analyser is a MALDI-TOF mass spectrometry immunoassay that is used in conjunction with the Binding Site Optilite IgG, IgA and IgM assays for the semi-quantitative in vitro measurement of monoclonal IgG, IgA, and IgM as a reflex test in serum for patients with a result suggestive of the presence of monoclonal immunoglobulins by serum protein electrophoresis (gel or capillary zone electrophoresis), or with an abnormal serum free light chain concentration and free light chain ratio result.
The assay is intended for use as an aid in the evaluation of monoclonal gammopathy of undetermined significance (MGUS); and as an aid in the diagnosis of smouldering multiple myeloma (SMM), multiple myeloma (MM), Waldenström's macroglobulinaemia, and AL amyloidosis.
Assay results should be used in conjunction with other laboratory and clinical findings.
EXENT Analyser:
The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction with the EXENT assays. The device is designed for professional in vitro diagnostic use only and it is not a device for self-testing.
The system consisting of the EXENT® Analyser and the EXENT® assays are intended for the in vitro measurements of analytes in human body fluids. It is designed to provide automation and integration of all the analytical steps (including liquid handling and MALDI-ToF mass spectrometry). The EXENT Analyser is designed to be used solely in combination with EXENT assays to measure a variety of analytes depending on the reagents. The device is designed for professional use only and it is not a device for self-testing.
The EXENT Analyser combines automated immunoassay with readout by MALDI-ToF mass spectrometry. It is a modular analyser, and the major components are described in Table 3 and illustrated schematically in Figure 1.
| Component | Description | Function |
|---|---|---|
| EXENT-iP® 500 | Automated liquid handler | Preparation of patient samples by magnetic bead immunoprecipitation assays for subsequent analysis by MALDI-ToF Mass spectrometry |
| EXENT-iX® 500 | MALDI-ToF mass spectrometer | Analysis of prepared patient samples by MALDI-ToF mass spectrometry |
| EXENT-iQ® software | Workflow and data management software | Management of the workflow between the EXENT-iP500 and EXENT-iX500 instruments. Data management including processing and results release. |
The EXENT-iP500 component is an automated liquid handler that prepares human body fluids using the EXENT assay specific reagents. The samples are prepared using magnetic beads that are coated with isotype-specific antibodies. Any unbound material is washed away during the sample preparation process. The EXENT-iP500 also manages the transfer of the prepared patient sample to the MALDI plate.
The EXENT-iX500 component is a MALDI-ToF mass spectrometer. Signals are produced by ionizing the compound or biological material under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass-to-charge ratios. The EXENT-iX500 is used to read samples prepared by the EXENT-iP500.
The EXENT-iQ software integrates sample preparation and MALDI-ToF mass spectrometry and is used for data storage and processing. It is the primary user interface used by the user to review and release results.
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(262 days)
The ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) assay is for in vitro diagnostic use in the quantitative measurement of autoantibodies against thyroid peroxidase in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system.
Anti-thyroid peroxidase (aTPO) measurements are used, in conjunction with a clinical assessment, as an aid in the diagnosis of autoimmune thyroiditis and/or Graves' disease.
The ADVIA Centaur Anti-Thyroid Peroxidase II (aTPOII) consists of:
- aTPOII ReadyPack® primary reagent pack (Lite Reagent, Solid Phase)
- aTPOII CAL
Devices sold separately and included in the ADVIA Centaur® Anti-Thyroid Peroxidase II (aTPOII) are: - ADVIA Centaur aTPOII MCM (MCM 1, MCM 2–4)
- ADVIA Centaur aTPOII QC
- ADVIA Centaur aTPOII DIL ReadyPack ancillary reagent pack
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(90 days)
Elecsys Phospho-Tau (181P) Plasma is an in vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein in human plasma on cobas e immunoassay analyzers.
The Elecsys Phospho-Tau (181P) Plasma assay result is intended to be used as an aid in the initial assessment for Alzheimer's disease and other causes of cognitive decline in adult patients aged 55 years and older, presenting with signs, symptoms, or complaints of cognitive decline. The result should be interpreted in conjunction with other clinical information.
A negative test result is consistent with a negative amyloid positron emission tomography (PET) scan result and reduced likelihood that a patient's cognitive impairment is due to amyloid pathology. These patients should be investigated for other causes of cognitive decline.
A positive test result may not be consistent with a positive amyloid PET scan result. Patients with an initial positive result should be further investigated to determine whether the amyloid pathology can be a cause of cognitive impairment.
In vitro electrochemiluminescence immunoassay (ECLIA) intended for the measurement of the phosphorylated Tau 181 protein (pTau181p) in human plasma.
Elecsys Phospho-Tau (181P) Plasma utilizes a sandwich test principle and has a total duration time of 18 minutes.
- 1st incubation: 30 µL of sample, biotinylated monoclonal antibody specific for phosphorylation at threonine 181, and a monoclonal tau-specific antibody labeled with a ruthenium complex^a) react to form a sandwich complex.
- 2nd incubation: After addition of streptavidin-coated microparticles, the complex becomes bound to the solid phase via interaction of biotin and streptavidin.
- The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell II M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier.
- Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the cobas link.
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