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510(k) Data Aggregation
K Number
K100682Device Name
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
Manufacturer
WALLAC OY
Date Cleared
2010-07-23
(135 days)
Product Code
JLX
Regulation Number
862.1395Why did this record match?
Product Code :
JLX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The GSP Neonatal 17α-OH-progesterone kit is intended for the quantitative determination of human 17α-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the GSP™ instrument.
Device Description
The GSP Neonatal 17x-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled 17-OHP and sample 17-OHP for a limited amount of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibody-bound and free antigen. DELFIA Inducer dissociates europium ions from the labeled antigen into solution where they form highly fluorescent chelates with components of DELFIA Inducer. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of 17-OHP in the sample.
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K Number
K081922Device Name
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
Manufacturer
WALLAC OY
Date Cleared
2009-04-16
(283 days)
Product Code
JLX
Regulation Number
862.1395Why did this record match?
Product Code :
JLX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AutoDELFIA® Neonatal 17a-OH-progesterone kit is intended for the quantitative determination of human 17a-OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA® automatic immunoassay system.
Device Description
The AutoDELFIA Neonatal 17α-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competitive reaction between europium-labeled 17-OHP and sample 17-OHP for a limited amount of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibody-bound and free antigen. Enhancement Solution dissociates europium ions from the labeled antigen into solution where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the concentration of 17-OHP in the sample.
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K Number
K062534Device Name
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
Manufacturer
DRG INTL., INC.
Date Cleared
2008-01-29
(518 days)
Product Code
JLX
Regulation Number
862.1395Why did this record match?
Product Code :
JLX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K060452Device Name
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
Manufacturer
NEO-GENESIS
Date Cleared
2007-03-13
(385 days)
Product Code
JLX
Regulation Number
862.1395Why did this record match?
Product Code :
JLX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Accuwell" 17α-Hydroxyprogesterone EIA Kit is designed for the quantitative measurement of 17α-Hydroxyprogesterone (17-OHP) concentrations in neonatal blood samples that have been collected onto Whatman 903® specimen collection paper. The results are used to screen newborns for classical congenital adrenal hyperplasia (CAH).
Device Description
The Accuwell" 17a-Hydroxyprogesterone EIA Kit is a competitive solid phase enzyme immunoassay (ElA) for the quantitative measurement of 17«-Hydroxyprogesterone (17-OHP) concentrations in neonatal blood samples that have been collected onto Whatman S&S 903" specimen collection paper. Standard control, and unknown dried blood spot sample discs are added to specified wells in a 90-well microplate coated with antiserum specific for 17-OHP.
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K Number
K050960Device Name
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
Manufacturer
WALLAC OY
Date Cleared
2005-07-11
(84 days)
Product Code
JLX
Regulation Number
862.1395Why did this record match?
Product Code :
JLX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for the quantitative determination of 17 a - OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA automatic immunoassay system.
Device Description
The AutoDELFIA Neonatal 17α-ΟΗ-progesterone (17-ΟΗΡ) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition between europium-labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibodybound and free antigen. Enhancement Solution dissociates europium ions from the labeled antiserum into solution, where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the quantity of 17-OHP in the sample.
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K Number
K042424Device Name
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
Manufacturer
WALLAC OY
Date Cleared
2004-09-30
(22 days)
Product Code
JLX
Regulation Number
862.1395Why did this record match?
Product Code :
JLX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for the quantitative determination of 17 a- OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH).
Device Description
The DELFIA Neonatal 17α-OH-progesterone (17-OHP) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition between europium-labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibodybound and free antigen. Enhancement Solution dissociates europium ions from the labeled antiserum into solution, where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the quantity of 17-OHP in the sample.
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K Number
K042425Device Name
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
Manufacturer
WALLAC OY
Date Cleared
2004-09-30
(22 days)
Product Code
JLX
Regulation Number
862.1395Why did this record match?
Product Code :
JLX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This kit is intended for the quantitative determination of 17 a- OH-progesterone in blood specimens dried on filter paper as an aid in screening newborns for congenital adrenal hyperplasia (CAH) using the 1235 AutoDELFIA automatic immunoassay system.
Device Description
The AutoDELFIA Neonatal 17α-ΟΗ-progesterone (17-ΟΗΡ) assay is a solid phase, time-resolved fluoroimmunoassay based on the competition between europium-labeled 17-OHP and sample 17-OHP for a limited number of binding sites on 17-OHP specific polyclonal antibodies (derived from rabbit). Danazol facilitates the release of 17-OHP from the binding proteins. A second antibody, directed against rabbit IgG, is coated to the solid phase, giving convenient separation of the antibodybound and free antigen. Enhancement Solution dissociates europium ions from the labeled antiserum into solution, where they form highly fluorescent chelates with components of the Enhancement Solution. The fluorescence in each well is then measured. The fluorescence of each sample is inversely proportional to the quantity of 17-OHP in the sample.
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K Number
K973350Device Name
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
Manufacturer
BIO-RAD
Date Cleared
1998-02-09
(157 days)
Product Code
JLX
Regulation Number
862.1395Why did this record match?
Product Code :
JLX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE BIO-RAD MICROPLATE 17- HYDROXYPROGESTERONE (17-OHP) TEST IS DESIGNED FOR THE QUANTITATIVE MEASUREMENT OF ιτα HYDROXYPROGESTERONE IN DRIED BLOOD SPOTS IT IS INTENDED FOR IN VITRO DIAGNOSTIC USE AS AN ALD IN SCREENING NEWBORNS FOR CONGENITAL, ADRENAL HYPERPLASIA.
Device Description
Not Found
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