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510(k) Data Aggregation
K Number
K191985Device Name
Optilite IgA Kit
Manufacturer
The Binding Site Group Ltd.
Date Cleared
2019-08-19
(25 days)
Product Code
CFN, JIT, JJX
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
The Binding Site Group Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optilite IgA Kit is intended for the quantitative in vitro measurement of IgA in serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgA aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. This test should be used in conjunction with other laboratory and clinical findings.
Device Description
The Optilite IgA Kit comprises the following reagents: Antiserum: Goat anti IgA supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.
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K Number
K191635Device Name
Optilite IgM Kit
Manufacturer
The Binding Site Group Ltd.
Date Cleared
2019-07-15
(26 days)
Product Code
CFN
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
The Binding Site Group Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optilite IgM Kit is intended for the quantitative in vitro measurement of IgM in human serum, lithium heparin or EDTA plasma using the Binding Site Optilite analyser. Measurement of IgM aids in the diagnosis of abnomal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
Device Description
The Optilite IgM Kit comprises the following reagents: Antiserum: Goat anti IgM supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material. Reaction Buffer: Containing 0.099% sodium azide as a preservative.
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K Number
K191465Device Name
Human IgM Kit for use on SPAPlus
Manufacturer
The Binding Site Group Ltd.
Date Cleared
2019-06-27
(24 days)
Product Code
CFN
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
The Binding Site Group Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for the quantitative in vitro determination of human IgM in human serum, lithium heparin or EDTA plasma, using the Binding Site SPAPLUS turbidimetric analyser. Measurement of IgM aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents. The test results are to be used in conjunction with other clinical and laboratory findings.
Device Description
The SPAPlus IgM Kit comprises the following reagents:
Antiserum: Goat Anti-IgM is supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, 0.1% E-amino-n-caproic acid (EACA), 0.5% BSA and 0.01% benzamidine.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Contain 0.099% sodium azide. 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.
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K Number
K190686Device Name
Optilite IgM CSF Kit
Manufacturer
The Binding Site Group Ltd.
Date Cleared
2019-05-28
(71 days)
Product Code
CFN
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
The Binding Site Group Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optilite IgM CSF Kit is intended for the quantitative in vitro measurement of IgM in cerebrospinal fluid (CSF) samples using the Optilite analyser.
Device Description
The Optilite IgM CSF Kit comprises the following reagents:
Latex Reagent: Supplied in stabilised liquid form. Preservatives: 0.025% sodium azide, 0.1% E-amino-n-caproic acid (EACA) and 0.01% benzamidine, 0.05% ProClin.
Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, 0.1% EACA and 0.01% benzamidine as preservatives. The concentration given on the quality control certificate has been obtained by comparison with the DA470k international reference material.
Reaction Buffer: Containing 0.099% sodium azide as a preservative.
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K Number
K183151Device Name
Optilite IgA CSF Kit
Manufacturer
The Binding Site Group Ltd.
Date Cleared
2019-01-23
(70 days)
Product Code
CFN
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
The Binding Site Group Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optilite IgA CSF Kit is intended for the quantitative in vitro measurement of IgA in cerebrospinal fluid (CSF) using the Optilite analyser.
Device Description
The Optilite IgA CSF Kit comprises the following reagents: Latex Reagent, Calibrator and Controls, and Reaction Buffer.
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K Number
K172868Device Name
Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls
Manufacturer
The Binding Site Group Ltd.
Date Cleared
2018-02-28
(161 days)
Product Code
DCN, SYS
Regulation Number
866.5270Why did this record match?
Applicant Name (Manufacturer) :
The Binding Site Group Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings.
The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser.
The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.
Device Description
The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following:
Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0.
Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.
The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.
The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.
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K Number
K172613Device Name
Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit
Manufacturer
The Binding Site Group Ltd.
Date Cleared
2018-02-15
(168 days)
Product Code
PCN, PCO
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
The Binding Site Group Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hevylite IgG Kappa kit is a quantitative in vitro assay intended for the measurement of IgG Kappa (IgG heavy chain and Kappa light chain intact immunoglobulin) in serum using the Optilite analyser. Measurement of Hevylite IgG Kappa is used alongside Hevylite IgG Lambda to calculate the IgG Lambda ratio. The Hevylite IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
The Hevylite IgG Lambda kit is a quantitative in vitro assay intended for the measurement of IgG heavy chain and Lambda light chain intact immunoglobulin) in serum using Site Optilite analyser. Measurement of Hevylite IgG Lambda is used alongside Hevylite IgG Kappa to calculate the IgG Kappa / IgG Lambda ratio. The Hevylite IgG Kappa / IgG Lambda ratio can be used when monitoring previously diagnosed IgG multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
Device Description
The Hevylite Human IgG Kappa and IgG Lambda Kits contain vials of ready-to-use polyclonal monospecific sheep anti-lgG antisera against combined γ heavy and κ light chain or combined y heavy and À light chain, calibrators (six levels), controls (low and high) and reaction buffer in liquid form. The reagents contain 0.099% sodium azide as preservative.
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K Number
K162263Device Name
Optilite Rheumatoid Factor Kit
Manufacturer
THE BINDING SITE GROUP LTD.
Date Cleared
2017-05-03
(265 days)
Product Code
DHR
Regulation Number
866.5775Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optilite Rheumatoid Factor (RF) Kit is intended for the quantitative in vitro measurement of rheumatoid factor in serum using the Binding Site Optilite analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings.
Device Description
The Optilite Rheumatoid Factor Kit comprises the following reagents: Reaction Buffer, Latex Reagent, RF Controls (supplied at 2 levels, Low and High), and RF Calibrator.
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K Number
K160819Device Name
Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit
Manufacturer
THE BINDING SITE GROUP LTD.
Date Cleared
2016-06-16
(84 days)
Product Code
OPX, OPY
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Optilite Hevylite IgA Kappa kit is a quantitative in vitro assay intended for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Kappa is used alongside Hevylite IgA Lambda to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
The Optilite Hevylite IgA Lambda kit is a quantitative in vitro assay intended for the measurement of IgA heavy chain and Lambda light chain intact immunoglobulin) in serum using the Binding Site Optilite analyser. Measurement of Hevylite IgA Lambda is used alongside Hevylite IgA Kappa to calculate the IgA Lambda ratio. The Hevylite IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
Device Description
Not Found
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K Number
K151759Device Name
Hevylite Human IgA Kappa Kit for use on SPAPLUS, Hevylite Human IgA Lambda Kit for use on SPAPLUS
Manufacturer
THE BINDING SITE GROUP LTD.
Date Cleared
2015-11-06
(130 days)
Product Code
OPX, OPY
Regulation Number
866.5510Why did this record match?
Applicant Name (Manufacturer) :
THE BINDING SITE GROUP LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Hevylite Human IgA Kappa is a quantitative in vitro assay performed on the Binding Site SPAPLUS for the measurement of IgA Kappa (IgA heavy chain and Kappa light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Kappa is used alongside Hevylite Human IgA Lambda to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
Hevylite Human IgA Lambda is a quantitative in vitro assay performed on The Binding Site SPAPLUS for the measurement of IgA Lambda (IgA heavy chain and Lambda light chain intact immunoglobulin) in serum. Measurement of Hevylite Human IgA Lambda is used alongside Hevylite Human IgA Kappa to calculate the IgA Kappa / IgA Lambda ratio. The Hevylite Human IgA Kappa / IgA Lambda ratio can be used when monitoring previously diagnosed IgA multiple myeloma patients and is used in conjunction with other laboratory tests and clinical evaluations. The assignment of complete response is reliant upon other tests including immunofixation, bone marrow and urine assessments.
Device Description
Not Found
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