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510(k) Data Aggregation
K Number
K041349Device Name
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM
Manufacturer
IBL GMBH
Date Cleared
2004-09-24
(127 days)
Product Code
CHP
Regulation Number
862.1260Why did this record match?
Product Code :
CHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Luminescence immunoassay for the in vitro diagnostic quantitative measurement of active free Estradiol, an estrogenic steroid, in saliva and serum. Measurements obtained by this device may be used in the diagnosis and treatment of various hormonal sexual disorders and can be used to evaluate ovarian function. This test is not intended for assessing placental function in complicated pregnancy.
Device Description
Luminescence immunoassay (LIA) based on the competition principle. An unknown amount of antigen present in the sample and a fixed amount of enzyme labeled antigen compete for the binding sites of the antibodies coated onto the wells. After incubation the wells are washed to stop the competition reaction. After addition of the luminescence substrate solution the intensity of the luminescence measured is inversely proportional to the amount of the antigen in the sample. Results of samples can be determined directly using the standard curve.
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K Number
K973901Device Name
17 B-ESTRADIOL (ELISA)
Manufacturer
KMI DIAGNOSTICS, INC.
Date Cleared
1997-11-24
(41 days)
Product Code
CHP
Regulation Number
862.1260Why did this record match?
Product Code :
CHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IBL Estradiol ELISA test kit is intended for the in vitro determination of estradiol, an estrogenic steroid, in human serum and plasma. Estradiol measurements are used in the diagnostics and treatment of various hormonal sexual disorders and in assessing placental function in complicated pregnancy.
Device Description
Not Found
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K Number
K973743Device Name
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Manufacturer
BECKMAN INSTRUMENTS, INC.
Date Cleared
1997-10-31
(30 days)
Product Code
CHP, JIS
Regulation Number
862.1260Why did this record match?
Product Code :
CHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access Estradiol assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of estradiol levels in human serum, using the Access Immunoassay System.
Device Description
The Access® Estradiol reagents and the Access® Immunoassay Analyzer comprise the Access® Immunoassay System for the quantitative determination of Estradiol levels in human serum.
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K Number
K970386Device Name
ACS ESTADIOL-6 II
Manufacturer
CHIRON DIAGNOSTICS CORP.
Date Cleared
1997-06-04
(121 days)
Product Code
CHP
Regulation Number
862.1260Why did this record match?
Product Code :
CHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Chiron Diagnostics ACS:180 Estradiol-6 II Assay is for the quantitative determination of estradial in serum and to aid in assessing ovarian function and in the monitoring of follicular development using the Chiron Diagnostics ACS:180 automated chemiluminescence systems.
Device Description
Not Found
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K Number
K970643Device Name
VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)
Manufacturer
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.
Date Cleared
1997-03-18
(26 days)
Product Code
CHP
Regulation Number
862.1260Why did this record match?
Product Code :
CHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K970126Device Name
ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)
Manufacturer
BIO-RAD LABORATORIES, INC.
Date Cleared
1997-02-25
(42 days)
Product Code
CHP
Regulation Number
862.1260Why did this record match?
Product Code :
CHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACCESS® Estradiol assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum using the ACCESS® Immunoassay System.
Device Description
The ACCESS® Estradiol reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of Estradiol levels in human serum.
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K Number
K965109Device Name
ELECSYS ESTRADIOL ASSAY
Manufacturer
BOEHRINGER MANNHEIM CORP.
Date Cleared
1997-02-18
(60 days)
Product Code
CHP
Regulation Number
862.1260Why did this record match?
Product Code :
CHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Immunoassay for the in vitro quantitative determination of estradiol in human serum and plasma.
Device Description
Competition principle. Total duration of assay: 18 minutes, 37 °C.
· 1st incubation (9 minutes): By incubating the sample (50 uL) with an estradiol-specific biotinylated antibody (65 uL), an immunocomplex is formed, the amount of which is dependent upon the analyte concentration in the sample.
·2nd incubation (9 minutes): After addition of streptavidin-coated microparticles (35 µL) and an estradiol derivative labeled with a ruthenium complex* (65 uL), the still-vacant sites of the biotinylated antibodies become occupied, with the formation of an antibody-hapten complex. The entire 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. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier (0.4 second read frame).
·Results are determined via a calibration curve which is instrumentspecifically generated by 2-point calibration and a master curve provided via the reagent bar code.
** Tris(2,2'-bipyridy))ruthenium(II) complex (Ru(bpy)" 3)
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K Number
K955647Device Name
VIDAS ESTRADIOL II (E2II) ASSAY
Manufacturer
BIOMERIEUX VITEK, INC.
Date Cleared
1996-02-06
(56 days)
Product Code
CHP
Regulation Number
862.1260Why did this record match?
Product Code :
CHP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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