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K Number
K203530Device Name
Albumin BCP2
Manufacturer
Abbott Ireland Diagnostics Division
Date Cleared
2022-03-18
(471 days)
Product Code
CJW
Regulation Number
862.1035Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Albumin BCP2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.
The Albumin BCP2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Device Description
The Albumin BCP2 assay is an automated clinical chemistry assay. The Albumin BCP2 procedure is based on the binding of bromocresol purple specifically with human albumin to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.
Methodology: Colorimetric (Bromocresol Purple)
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K Number
K203248Device Name
Albumin BCG2
Manufacturer
Abbott Ireland Diagnostics Division
Date Cleared
2021-11-23
(384 days)
Product Code
CIX
Regulation Number
862.1035Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Albumin BCG2 assay is used for the quantitation of albumin in human serum or plasma on the ARCHITECT c System.
The Albumin BCG2 assay is to be used as an aid in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Device Description
The Albumin BCG2 assay is an automated clinical chemistry assay. The Albumin BCG2 procedure is based on the binding of bromocresol green in the assay reagent specifically with albumin in the patient sample to produce a colored complex. The absorbance of the complex at 604 nm is directly proportional to the albumin concentration in the sample.
Methodology: Colorimetric (Bromocresol Green)
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K Number
K200898Device Name
Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin
Manufacturer
Medicon Hellas, S.A
Date Cleared
2021-09-21
(536 days)
Product Code
CIX, CDQ, CFR, CGX, CIG, CJY
Regulation Number
862.1035Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medicon Hellas Albumin: Reagent for the quantitative measurement of albumin in serum. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Medicon Hellas Calcium: Reagent for the quantitative measurement of calcium in serum or urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).
Medicon Hellas Creatinine: Reagent for the quantitative measurement of creatinine in serum and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Medicon Hellas Glucose: Reagent for the quantitative measurement of glucose in serum and urine. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Medicon Hellas Direct Bilirubin; Reagent for the quantitative measurement of direct bilirubin (conjugated) in serum. Measurements of the level of direct bilirubin is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall blader block.
Medicon Hellas Total Bilirubin: Reagent for the quantitative measurements of total bilirubin in serum. Measurements of the levels of total bilirubin is used in the diagnosis and treatment of liver. hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
Medicon Hellas Urea Nitrogen: Reagent is for the quantitative measurement of urea nitrogen in serum and urine. Measurements are used in the diagnosis and treatment of certain renal and metabolic diseases.
Device Description
The Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Glucose, Medicon Hellas Direct Bilirubin, Medicon Hellas Total Bilirubin, and Medicon Hellas Urea Nitrogen are reagents for use with Diatron Pictus 500 Clinical Chemistry Analyzers. They are test systems for the quantitative measurement of albumin, calcium, creatinine, glucose, direct and total bilirubin, and urea nitrogen in human serum and urine where clinically applicable. The methods employed are photometric, utilizing reactions between the sample and reagents to produce a colored chromophore or a change in absorbance that is proportional to the concentration of the analyte. The analyzer photometer reads the absorbances at time intervals dictated by the method application stored in the analyzer memory, and the change in absorbance is calculated automatically.
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K Number
K193001Device Name
Albumin BCP
Manufacturer
Sentinel CH. SpA
Date Cleared
2019-12-19
(52 days)
Product Code
CJW
Regulation Number
862.1035Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Albumin BCP assay is an in vitro diagnostic test used for the determination of albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The assay is intended for professional use only.
For In Vitro Diagnostic use only.
Device Description
Albumin BCP reagent is ready to use liquid reagent that is supplied in two configurations: fill volume 20 mL in a 20 mL wedge or 50 mL in a 50 mL wedge, 6 wedges/kit.
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K Number
K191245Device Name
Yumizen C1200 ALP, Yumizen C1200 Albumin
Manufacturer
HORIBA ABX SAS
Date Cleared
2019-08-30
(113 days)
Product Code
CJE, CIX
Regulation Number
862.1050Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Yumizen C1200 ALP reagent is intended for the quantitative in vitro diagnostic determination of alkaline phosphatase in human serum and plasma based on a kinetic photometric test using p-Nitropherylphosphate. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
Yumizen C1200 Albumin reagent is intended for the quantitative in vitro diagnostic determination of albumin in human serum and plasma by colorimetry. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Device Description
Not Found
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K Number
K191316Device Name
VITROS XT Chemistry Products ALB-TP Slides
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Date Cleared
2019-06-07
(23 days)
Product Code
CIX
Regulation Number
862.1035Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Rx Only
For in vitro diagnostic use only
The ALB test within the VITROS XT Chemistry Products ALB-TP Slides quantitatively measures albumin (ALB) concentration in serum and plasma using the VITROS XT 7600 Integrated System. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Device Description
The new device, the VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur and test results are generated for each analyte independently of the other analyte.
The ALB test is a multilayered, analytical element coated on a polyester support.
For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromcresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample.
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K Number
K170901Device Name
ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
Manufacturer
BioSystems S.A.
Date Cleared
2018-04-13
(382 days)
Product Code
CIX, CFR, CJE, JJE
Regulation Number
862.1035Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BA400: The BA400 analyser is used to determine analyte concentrations by in vitro biochemical and turbidimetric measurements of human samples of serum, urine, plasma, cerebrospinal fluid or total blood. This device is intended to replace manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity.
ALBUMIN: Reagent for the measurement of albumin concentration in human serum or plasma. The obtained values are useful as an aid in the evaluation of protein synthesis of the liver in the chronic liver diseases and for the nutritional status. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
ALKALINE PHOSPHATASE (ALP) - AMP: Reagent for the measurement of alkaline phosphatase (ALP)-AMP concentration in human serum or plasma. The obtained values are useful as an aid in the diagnosis and treatment of hepatobiliary and bone diseases with impaired osteoblastic activity diseases. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
GLUCOSE-HEXOKINASE: Reagent for the measurement of glucose concentration in human serum, plasma, urine or cerebrospinal fluid. The obtained values are useful as an aid in the diagnosis and monitoring of the diabetes mellitus. This reagent is for use in the BioSystems BA analyzers. Only for in vitro use in the clinical laboratory.
Device Description
Not Found
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K Number
K161954Device Name
Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
Manufacturer
Siemens Healthcare Diagnostics
Date Cleared
2017-03-09
(234 days)
Product Code
JGS, CEM, CGZ, CJW, JJE, JLW, LEH
Regulation Number
862.1665Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Siemens Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
The Atellica™ A-L YTE Integrated Multisensor (Na, K, Cl) is intended for in vitro diagnostic use in the quantitative determination of sodium, potassium, and chloride (Na, K, Cl) in human serum, plasma, and urine using the Atellica™ CH system. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Atellica™ CH Albumin BCP Reagent (Alb P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on Atellica™ CH system. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Atellica™ IM Thyroid Stimulating Hormone (TSH) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum, and plasma (EDTA and lithium heparin) using the Atellica™ IM system. Measurements of the thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
The Atellica™ CH Vancomycin (Vanc) assay is for in vitro diagnostic use in the quantitative measurement of vancomycin in human serum or plasma on the Atellica™ CH System. Vanc test results may be used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to ensure appropriate therapy.
Device Description
The Atellica™ Solution is a multi-component system for in vitro diagnostic testing of clinical specimens. The system is intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use. The Atellica™ Solution consists of any combination of Atellica Sample Handler component, an Atellica Magline Magnetic Sample Transport system component, Atellica IM and all software and hardware needed to support a customizable array of analyzers. The submission also covers the Atellica™ A-LYTE Integrated Multisensor (Na, K, Cl), Atellica™ CH Albumin BCP Reagent (Alb P), Atellica™ IM Thyroid Stimulating Hormone (TSH) assay, and Atellica™ CH Vancomycin (Vanc) assay, which are reagents/assays used with the Atellica Solution.
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K Number
K151767Device Name
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Date Cleared
2015-12-11
(164 days)
Product Code
JGS, CEM, CGZ, CJW, JIT, JIX, JJE
Regulation Number
862.1665Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system's chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.
The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The TD-LYTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.
The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.
The Albumin BCP Reagent (Alb) P) is intended for in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Albumin BCP calibrator is for in vitro diagnostic use in the Trinidad CH Albumin BCP Assay (Alb P) on the Trinidad CH System.
Device Description
The Siemens Healthcare Diagnostics Trinidad CH System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric and integrated ion selective multisensor detection technologies for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).
Na, K, Cl uses indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ion selective for sodium, potassium and chloride. A reference electrode is also incorporated in the multisensor.
A diluted sample (1:10 with IMT Diluent) is positioned in the sensor and Na*, K* or Cl ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.
Serum, plasma and urine specimens may be used. The sensor is stored unopened at 2 – 8 °C and is stable for use on board for 14 days or 5000 samples.
The Trinidad CH System TD-LYTE Integrated Multisensor system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power-on, with the changing of standards A. B. or a sensor and when the system software is reset.
The target concentrations of the TD-LYTE IMT Standard A include: Nat at 14 mmol/L, K* at 0.4 mmol/L and Cl¯ at 10.4 mmol/L. The target concentrations of the TD-LYTE Standard B include: Na 7 mmol/L, K* at 6 mmol/L and Cli at 16 mmol/L. The target concentrations of the Salt Bridge include: K* at 120.0 mmol/L and Cl¯ at 120.3 mmol/L.
The Trinidad CH System Albumin BCP Reagent (Alb_P) assay is an adaptation of the bromocresol purple (BCP) dye-binding method reported by Carter and Louderback, et al. In the Trinidad CH System , the Alb_P assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm.
Alb P is calibrated with Trinidad CH Diluent(11099300) and ALBP Calibrator (1 level). It is a 2-point linear curve.
Serum and plasma specimen types may be used. The reagent is stored at 2 - 8 °C and each well is stable on the sytem for 20 days.
The Albumin BCP (Alb P) calibrator is a lyophilized human serum-based product containing albumin. It is used to calibrate the Albumin BCP (Alb_P) assay on the Trinidad CH System.
The target concentration of the albumin is 4.3 g/dL.
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K Number
K132664Device Name
ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Date Cleared
2013-10-16
(50 days)
Product Code
CJW, JIX
Regulation Number
862.1035Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on ADVIA Chemistry systems. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
For in vitro diagnostic use in the calibration of the ADVIA Chemistry Albumin BCP Assay (ALBP) on ADVIA Chemistry systems.
Device Description
The Albumin BCP reagents are ready-to-use liquid reagents packaged for use on the automated ADVIA 1650 Chemistry systems. Reagents are supplied in two configurations: fill volume of 18 mL in a 20 mL wedge or 35 mL in a 40 mL wedge, 4 wedges/kit.
The calibrator is a multi-analyte human serum based product containing albumin derived from human serum. The kit consists of 3 vials of one-level calibrator which are lyophilized. The target concentration of this calibrator is 4.3 g/dL. The volume per vial (after reconstitution with deionized water) is 2.0 mL.
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