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510(k) Data Aggregation
K Number
K240182Device Name
Access EPO
Manufacturer
Beckman Coulter Inc
Date Cleared
2024-04-22
(90 days)
Product Code
GGT
Regulation Number
864.7250Why did this record match?
Product Code :
GGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
Device Description
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias.
The Access EPO Calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
The Access EPO assay is a two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with the paramagnetic particles coated with mouse monoclonal anti-EPO, blocking reagent and the alkaline phosphatase conjugate. After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
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K Number
K183088Device Name
ADVIA Centaur Erythropoietin (EPO) assay
Manufacturer
Axis-Shield Diagnostics Limited
Date Cleared
2019-08-02
(269 days)
Product Code
GGT
Regulation Number
864.7250Why did this record match?
Product Code :
GGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ADVIA Centaur® Erythropoietin (EPO) assay is for in the quantitative measurement of exythropoitin in pediatric and adult human serum or plasma (K2-EDTA, lithium heparin) using the ADVIA Centaur XP system. Measurement of erythropoietin is used as an aid in the diagnosis of anemias and polycythemias.
Device Description
The ADVIA Centaur EPO assay is a fully automated, one-step sandwich immunoassay using direct chemiluminescent technology. The assay utilizes an acridinium-ester-labeled monoclonal mouse anti-EPO antibody in the Lite Reagent. The Solid Phase consists of mouse anti-EPO monoclonal antibody-coated paramagnetic microparticles.
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K Number
K052223Device Name
ACCESS EPO ASSAY
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2006-10-06
(417 days)
Product Code
GGT, JIT
Regulation Number
864.7250Why did this record match?
Product Code :
GGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access EPO assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of erythropoietin levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
The Access EPO calibrators are intended to calibrate the Access EPO assay for the quantitative determination of EPO levels in human serum and plasma (heparin) using the Access Immunoassay Systems.
Device Description
The Access® EPO assay consists of the reagent pack and calibrators. Other items needed to perform the assay include the Access substrate and wash buffers.
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K Number
K992799Device Name
SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT
Manufacturer
SANGUI BIOTECH, INC.
Date Cleared
2000-06-07
(293 days)
Product Code
GGT
Regulation Number
864.7250Why did this record match?
Product Code :
GGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of this product is the quantitative determination of erythropoietin levels in human serum. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.
Device Description
Quantitative determination of EPO [Erythropoietin] in human serum. This immunoassay is based on the principles of the two site "sandwich" Enzyme-Linked ImmunoSorbent Assay (ELISA).
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K Number
K983203Device Name
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
Manufacturer
DIAGNOSTIC PRODUCTS CORP.
Date Cleared
1999-07-12
(301 days)
Product Code
GGT
Regulation Number
864.7250Why did this record match?
Product Code :
GGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMMULITE EPO is a solid-phase, two-site sequential chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of erythropoietin (EPO) in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis of anemias and polycythemias.
Device Description
IMMULITE® EPO is a solid-phase, two-site chemiluminescent sequential enzyme immunometric assay for use with the IMMULITE® Automated Immunoassay Analyzer
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K Number
K980737Device Name
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
Manufacturer
NICHOLS INSTITUTE DIAGNOSTICS
Date Cleared
1999-03-23
(391 days)
Product Code
GGT
Regulation Number
864.7250Why did this record match?
Product Code :
GGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nichols Advantage™ Chemiluminescence Erythropoietin Immunoassay is intended for use with the Nichols Advantage™ Specialty System for the quantitative determination of erythropoietin concentrations in human serum as an adjunct in the diagnosis of anemia and polycythemia.
Device Description
The Nichols Advantage™ EPO assay is a two-site chemiluminescence assay. Total assay duration is 30 minutes at 37°C.
14 Incubation: 20 minutes at 37℃. Sample or control (200uL), biotinylated polyclonal antibody (40uL), acridinium labeled mouse monoclonal antibody (10uL) are pipetted into a reaction well on the cuvette strip. Each antibody binds to a separate and distinct antigenic site on EPO to form a sandwich complex.
204 Incubation: 10 minutes at 37°C. Streptavidin coated magnetic particles (20uL) are added to the reaction mixture. After the 10 minute incubation, the sandwich complex is bound to the solid phase via the high affinity interaction of blotin and streptavidin. The reaction mixture is aspirated from the reaction well after the streptavidin magnetic particles are magnetically capfured onto the surface of the reaction well wall.
Acridinum esters emit light upon treatment with hydrogen peroxide and an alkaline solution. The Trigger 1 solution contains hydrogen peroxide in dilute acid and Trigger 2 solution contains sodium hydroxide. The system automatically injects Trigger 1 and 2 into the reaction well which oxidizes the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light which is quantified in 2 seconds, and is expressed in relative light units (RLU) by the integrated system luminometer.
The amount of bound labeled antibody in RLU's is directly proportional to the concentration of EPO in the sample. Results are determined via a calibration curve which is instrument-specifically generated by 2-point calibration and a master curve provided via the reagent bar codes.
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K Number
K952559Device Name
ERYTHROPOIETIN IMMUNOASSAY KIT
Manufacturer
NICHOLS INSTITUTE
Date Cleared
1996-05-29
(362 days)
Product Code
GGT
Regulation Number
864.7250Why did this record match?
Product Code :
GGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K954898Device Name
PREDICTA ERYTHROPOIETIN KIT (MODIFICATION)
Manufacturer
GENZYME CORP.
Date Cleared
1996-02-05
(138 days)
Product Code
GGT
Regulation Number
864.7250Why did this record match?
Product Code :
GGT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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