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Found 6 results
510(k) Data Aggregation
K Number
K240800Device Name
Access Intrinsic Factor Ab
Manufacturer
Beckman Coulter Inc
Date Cleared
2024-05-03
(39 days)
Product Code
LIG
Regulation Number
862.1810Why did this record match?
Product Code :
LIG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems.
It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
Device Description
The Access Intrinsic Factor Ab assay is a competitive binding immunoenzymatic assay. The Access assay consists of the reagent pack, calibrators and QCs. Other items needed to run the assay include substrate and wash buffer. The Access assay reagent pack, Access assay calibrators, Access QCs, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.
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K Number
K071346Device Name
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
Manufacturer
IMMCO DIAGNOSTICS, INC.
Date Cleared
2007-09-24
(133 days)
Product Code
LIG
Regulation Number
862.1810Why did this record match?
Product Code :
LIG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of intrinsic factor antibodies in human serum to aid in the diagnosis of pernicious anemia.
Device Description
An enzyme linked immunoassay (ELISA)
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K Number
K061841Device Name
QUANTA LITE INTRINSIC FACTOR ELISA
Manufacturer
INOVA DIAGNOSTICS, INC.
Date Cleared
2006-12-22
(176 days)
Product Code
LIG
Regulation Number
862.1810Why did this record match?
Product Code :
LIG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The QUANTA Lite™ Intrinsic factor ELISA is an enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative detection of Intrinsic factor antibodies in human serum. The presence of Intrinsic factor antibodies can be used in conjunction with clinical findings and other laboratory tests to aid in the diagnosis of pernicious anemia.
Device Description
Not Found
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K Number
K033603Device Name
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
Manufacturer
BECKMAN COULTER, INC.
Date Cleared
2003-12-19
(32 days)
Product Code
LIG, JIT, JJX
Regulation Number
862.1810Why did this record match?
Product Code :
LIG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Access Intrinsic Factor Ab assay is a paramagnetic particle, chemiluminescent immunoassay for the detection of intrinsic factor antibody in human serum and plasma using the Access Immunoassay Systems. It is intended for in vitro diagnostic use as an aid in the diagnosis of pernicious anemia.
Device Description
The Access Intrinsic Factor Ab reagents, calibrators, QC, and the Access Immunoassay Analyzers (Access, Access 2, Synchron LXi 725, and UniCel Dxl 800) comprise the Access Immunoassay Systems for the detection of intrinsic factor antibody in human serum and plasma.
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K Number
K993251Device Name
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
Manufacturer
DIAGNOSTIC PRODUCTS CORP.
Date Cleared
1999-11-17
(50 days)
Product Code
LIG
Regulation Number
862.1810Why did this record match?
Product Code :
LIG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
IMMULITE 2000 Vitamin B12 is for in vitro diagnostic use with the IMMULITE 2000 Analyzer for the quantitative measurement of vitamin B12 in serum or heparinized plasma, as an aid in clinical diagnosis and treatment of anemia.
Device Description
IMMULITE® 2000 Vitamin B12 is a clinical device for use with the IMMULITE 2000 Automated Immunoassay Analyzer. IMMULITE® and IMMULITE® 2000 Vitamin B12 are chemiluminescent immunoassays. The technology in DPC's IMMULITE® 2000 Vitamin B12 is a unique combination of technologies employed in previously cleared and commercially marketed DPC products. The IMMULITE 2000 Vitamin B12 assay begins with a one-cycle sample treatment of patient serum or plasma with dithiothreitol (DTT) and a sodium hydroxide/potassium cyanide solution (NaOH/KCN) in a reaction tube containing no bead. After a 30-minute incubation, the treated sample is transferred to a second reaction tube containing a vitamin B12-coated polystyrene bead, hog intrinsic factor (HIF) and an alkaline phosphatase-labeled antibody specific for HIF. During a 30-minute incubation, the vitamin B12 released from endogenous binding proteins during sample treatment competes with immobilized vitamin B12 for binding with HIF. Alkaline phosphatase-labeled anti-HIF antibody binds to HIF and is immobilized only if HIF is bound to the B12-coated bead. Unbound enzyme conjugate is removed by centrifugal wash. Substrate is added. The chemiluminescent substrate, a phosphate ester of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to yield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound comblex - and thus also the photon output, as measured by the luminometer - is inversely proportional to the concentration of vitamin B12 in the sample.
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K Number
K984108Device Name
ABBOTT ARCHITECT B12
Manufacturer
ABBOTT LABORATORIES
Date Cleared
1999-02-03
(78 days)
Product Code
LIG
Regulation Number
862.1810Why did this record match?
Product Code :
LIG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Abbott ARCHITECT™ B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of B12 in human serum and plasma on the Abbott ARCHITECT™ i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.
Device Description
The ARCHITECT B12 assay is a Chemiluminescent Microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma (tripotassium EDTA). The ARCHITECT B12 assay is calibrated with Abbott ARCHITECT B12 Calibrators. Abbott B12 Controls are assayed for the verification of the accuracy and precision of the Abbott ARCHITECT™ i System.
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