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The ADVIA Centaur EBV-EBNA IgG (EBVnaG) assay is for in vitro diagnostic use in the qualitative detection of IqG antibodies to Epstein-Barr virus (EBV) nuclear antigen (EBNA) in human pediatric (2-21 years old) and adult serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. When used in conjunction with other EBV markers, this assay is intended for use as an aid in the diagnosis of Epstein-Barr virus infection, such as infectious mononucleosis.

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The ADVIA Centaur EBV-VCA IgM (EBVM) assay is for in vitro diagnostic use in the qualitative detection of lgM antibodies to the viral capsid antigen (VCA) of the Epstein-Barr virus (EBV) in human pediatric (2-21 years old) and adult serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. When used in conjunction with other EBV markers, this assay is intended for use as an aid in the diagnosis of Epstein-Barr virus infection, such as infectious mononucleosis.

The ADVIA Centaur EBV-VCA IgM assay is a fully automated 2-step sandwich immunoassay using acridinium ester chemiluminescent technology. The specimen is incubated with the Ancillary Well Reagent and the Solid Phase, which contains an EBV-VCA IgM specific antigen. Antigen-antibody complexes will form if anti EBV-VCA IgM antibody is present in the specimen. The Lite Reagent contains monoclonal anti-human IgM labeled with acridinium ester and is used to detect EBV-VCA IgM in the specimen.

The Lp(a) Calibrators are for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems. The Lp(a) Control I and Control II are intended for use as assayed quality control materials for the quantitative monitoring of Lipoprotein (a) with the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems. For in vitro diagnostic use.

The Lp (a) Calibrators are a set of 5 levels required to establish the calibration curve of the Quantia Lipoprotein (a) reagents (K050487) for the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma using immunoturbidimetry technology on the ARCHITECT c Systems. The Lp (a) Control are a set of 2 levels used to monitor the quantitative measurement of Lipoprotein (a) concentration in human serum or plasma with the Quantia Lipoprotein (a) reagents (K050487) using immunoturbidimetry technology on the ARCHITECT c Systems. Quantia Lp(a) Reagent included two equivalent reagents presentation that only differ on the geographic distribution zone: - Reference 7K00-40 Quantia Lp(a) Reagent (US) - - Reference 7K00-01 Quantia Lp(a) Reagent (EX-US) Both Quantia Lp(a) Reagents reference will use the Lp(a) Calibrators and Lp(a) Control products. The human serum used in the Lp(a) Calibrators and Lp(a) Control is nonreactive for HBsAg, anti-HIV-1/HIV-2, and anti-HCV using FDA approved methods.

The ARCHITECT i Vancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT i Vancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy.

The ARCHITECT i Vancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The anti-vancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.

The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of 25-hydroxyvitamin D (25-OH vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. The ARCHITECT 25-OH Vitamin D Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of 25-hvdroxyvitamin D (25-OH Vitamin D) in human serum and plasma. The ARCHITECT 25-OH Vitamin D Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of 25-hydroxyvitamin D (25-OH Vitamin D) in human serum and plasma. For in vitro diagnostic use. Prescription Use

The ARCHITECT 25-OH Vitamin D assay is a delayed one-step immunoassay including a sample pre-treatment for the quantitative determination of vitamin D in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample and pre-treatment reagent are combined. An aliquot of the pre-treated sample is combined with assay dijuent and paramagnetic anti-vitamin D coated microparticles to create a reaction mixture. Vitamin D present in the sample binds to anti-vitamin D coated microparticles. After incubation a biotinylated vitamin D anti-Biotin acridinium-labeled conjugate complex is added to the reaction mixture and binds to unoccupied binding sites of the anti-vitamin D coated microparticles. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vitamin D in the sample and the RLUs detected by the ARCHITECT i System optics.

The ARCHITECT iDigoxin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of digoxin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The measurements obtained are used to aid in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to help ensure appropriate therapy. The ARCHITECT iDigoxin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of digoxin in human serum or plasma. For in vitro diagnostic use.

The ARCHITECT iDigoxin assay is a one-step STAT immunoassay for the quantitative measurement of digoxin in human serum or plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex. Sample, antidigoxin coated paramagnetic microparticles, assay diluent, and digoxiqenin acridinium-labeled conjugate are combined to create a reaction mixture. The antidigoxin coated microparticles bind to digoxin present in the sample and to the digoxigenin acridinium-labeled conjugate. After washing, pre-trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of digoxin in the sample and the RLUs detected by the ARCHITECT i System optics.

The ARCHITECT C-Peptide Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine. The ARCHITECT C-Peptide Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of C-peptide in human serum, plasma and urine. For in vitro diagnostic use.

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The ARCHITECT iVancomycin assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative measurement of vancomycin in human serum or plasma on the ARCHITECT i System with STAT protocol capability. The ARCHITECT iVancomycin assay is used in the diagnosis and treatment of vancomycin overdose and in monitoring levels of vancomycin to help ensure appropriate therapy. The ARCHITECT iVancomycin Calibrators are for the calibration of the ARCHITECT i System with STAT protocol capability when used for the quantitative determination of vancomycin in human serum or plasma. For in vitro diagnostic use.

The ARCHITECT iVancomycin assay is a one-step STAT immunoassay for the quantitative measurement of vancomycin in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample, anti-vancomycin coated paramagnetic microparticles, and vancomycin acridinium-labeled conjugate are combined to create a reaction mixture. The antivancomycin coated microparticles bind to vancomycin present in the sample and to the vancomycin acridinium-labeled conjugate. After washing, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). An indirect relationship exists between the amount of vancomycin in the sample and the RLUs detected by the ARCHITECT i System optics.

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2microglobulin concentration in human serum, plasma (EDTA) or urine on the AEROSET® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease. The Quantia Beta-2 Microglobulin is intended to be used with the already cleared Quantia PROTEINS Control (K050596) and the Beta-2 Microglobulin Standard (k050613).

The Quantia Beta-2 Microglobulin is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of beta-2-microglubulin concentration in human serum, plasma (EDTA) or urine on the AEROSET ® Instrument as an aid in the diagnosis of active rheumatoid arthritis and kidney disease. Quantia Beta-2-Microglobulin reagent was already 510(k) cleared as Quantia Beta-2-Microglobulin for its use with serum and EDTA plasma (K050613). A new submission for the Quantia Beta-2-Microglobulin reagent has been prepared as it is intended to also claim urine as a sample. The kit Quantia Beta-2-Microglobulin already cleared, contained Buffer and Latex Reagent. The Calibrators were already cleared in the submission K050613. There have also been added two different levels of controls in a separate kit. The controls are supplied by Bio-Rad (K851202/A1) and the values are assigned at Biokit S.A. This test with Biokit labeling was cleared k050596.

The ARCHITECT Intact PTH assay is an in vitro chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Intact PTH assay is intended to be used as an aid in the differential diagnosis of hpyercalcemia, hypocalcemia and parathyroid disorders. The ARCHITECT Intact PTH Calibrators are for the ARCHITECT i System when used for the quantitative determination of intact PTH in human serum and plasma. The ARCHITECT Intact PTH Controls are for the use in quality control to monitor the accuracy and precision of the ARCHITECT Intact PTH assay on the ARCHITECT i System for human serum and plasma. For in vitro diagnostic use.

The ARCHITECT Intact PTH assay is a two-step sandwich immunoassay for the quantitative determination of intact PTH in human serum and plasma using CM1A technology with flexible assay protocols, referred to as Chemiflex®. In the first step, sample, assay diluent, and anti-PTH coated paramagnetic microparticles are combined. Intact PTH present in the sample binds to anti-PTH coated microparticles. After washing, the anti-PTH acridinium-labeled conjugate is added to create a reaction mixture in the second step. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of intact PTH in the sample and the RLUs detected by the ARCHITECT i System optics. The concentration of intact PTH in the sample is determined by comparing the chemiluminescent signal in the reaction to the ARCHITECT Intact PTH calibration.