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The Access OV Monitor assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of CA 125 antigen levels in human serum and plasma using the Access Immunoassay Systems. This device is indicated for use in the measurement of CA 125 antigen to aid in the management of ovarian cancer patients. Serial testing for patient CA 125 antigen concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

The Access OV Monitor assay is a sandwich immunoenzymatic assay. The Access OV Monitor assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access OV Monitor assay reagent pack, Access OV Monitor assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassay Analyzer in a clinical laboratory setting.

For in vitro diagnostic use with the IMMULITE® 1000 Analyzers - for the quantitative measurement of CA125 antigen in serum, as an aid in monitoring the response to therapy for patients with epithelian ovarian cancer, and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second look procedures. For in vitro diagnostic use with the IMMULITE® 2000 Systems Analyzers - for the quantitative measurement of CA125 antigen in serum, as an aid in monitoring the response to therapy for patients with epithelian ovarian cancer, and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures.

The IMMULITE®/IMMULITE 1000 OM-MA Assay is comprised of OM-MA Test Units (beads coated with murine monoclonal anti-CA125 antibody), OM-MA Cycle 1 Reagent Wedge (alkaline phosphatase conjugated to rabbit polyclonal anti-CA125 antibody in buffer), OM-MA Cycle 2 Reagent Wedge (buffer), and OM-MA Adjustors (Low and High, CA125 in a nonhuman protein/buffer matrix). The IMMULITE® 2000 OM-MA Assay is a newer generation instrument that dispenses an individual bead from a pack into a separate reaction tube. It is comprised of OM-MA Bead Pack (beads coated with murine monoclonal anti-CA125 antibody), OM-MA Reagent Wedge (Well 1: alkaline phosphatase conjugated to rabbit polyclonal anti-CA125 antibody in buffer; Well 2: buffer), and OM-MA Adjustors (Low and High, CA125 in a nonhuman protein/buffer matrix). Both assays are solid-phase, two-site chemiluminescent immunometric assays that measure CA125 antigen quantitatively in serum.

For the quantitative measurement of OC 125 defined antigen concentration in human serum and plasma (EDTA or heparin) using the VITROS 5600 Integrated System. The VITROS CA 125 II assay is to be used as an aid in monitoring response to therapy for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay concentrations should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

The VITROS Immunodiagnostic Products CA 125 II Reagent Pack (test) is performed using the VITROS CA 125 II Reagent Pack and VITROS CA 125 II Calibrators on the VITROS 5600 System. An immunometric immunoassay technique is used, which involves the reaction of OC 125 present in the sample with a microwell coated with biotinylated Antibody (Mouse monoclonal anti-OC 125) bound to Streptavidin, and a Horseradish Peroxidase (HRP)-labelled antibody conjugate (Mouse monoclonal anti- OC 125). Unbound (HRP)-labeled anti-OC 125 antibody conjugate is removed by washing. The bound HRP conjugate is measured by a luminescent reaction. A reagent containing luminogenic substrates (a luminol derivative and a peracid salt) and an electron transfer agent, is added to the wells. The HRP in the bound conjugate catalyzes the oxidation of the luminol derivative, producing light. The electron transfer agent (a substituted acetanilide) increases the level of light produced and prolongs its emission. The light signals are read by the system. The amount of conjugate bound is directly proportional to the concentration of OC 125 present in the sample.

For in vitro diagnostic use in the quantitative, serial determination of CA 125 in human serum and plasma (EDTA and lithium heparin) and to aid in the management of patients with ovarian carcinoma using the ADVIA Centaur® XP and ADVIA Centaur® XPT systems. The test is intended for use as an aid in monitoring patients previously treated for ovarian cancer. Serial testing for CA 125 in the serum and plasma of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of ovarian cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. It is recommended that the ADVIA Centaur CA 125II assay be used under the order of a physician trained in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system.

The ADVIA Centaur CA 125II assay is comprised of the following reagents: CA 125II Lite Reagent (monoclonal mouse anti-M11 antibody labeled with acridinium ester and monoclonal mouse anti-OC 125 labeled with fluorescein in phosphate buffer with bovine serum albumin and preservatives) and CA 125II Solid Phase Reagent (monoclonal mouse anti-fluorescein antibody coupled to paramagnetic particles in phosphate buffer with bovine serum albumin and preservatives).

Elecsys CA 125 II is an immunoassay for the in vitro quantitative determination of OC 125 reactive determinants in human serum, Li heparin, K2-EDTA, as well as Li-heparin plasma tubes containing separating gel on the cobas e 411 analyzer. These determinants are associated with a high molecular weight glycoprotein in serum and plasma of women with primary epithelial invasive ovarian cancer (excluding those with cancer of low malignant potential). This immunoassay is indicated for use as an aid in the detection of recurrent ovarian carcinoma. This immunoassay is further indicated for use in monitoring patients for disease progress or response to therapy. The electrochemiluminescence immunoassay "ECLIA" is intended for use on the cobas e 411 immunoassay analyzers. For use in the verification of the callbration established by the Elecsys CA 125 II reagent on the Elecsys and cobas e immunoassay analyzers.

The CA 125 II assay employs a sandwich test principle using biotinylated monoclonal CA 125-specific antibody and a monoclonal CA 125-specific antibody labeled with a ruthenium complex to form a sandwich complex. The use of streptavidin-coated microparticles serves as the solid phase for the electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve (5-point-calibration) provided with the reagent bar code. The CA 125 II application is identical to the predicate assay (k972162). This submission is being done to modernize the labeling by adding the LoB, LoD and LoQ data and to change the sample:reagent ratio from 40:60μL to 20:70μL. Additionally, based on internal stability data the calibration frequency has been extended from 4 to 8 weeks. The Elecsys CA 125 II CalCheck is a lyophilized product consisting of equine serum in level 1 and human serum matrix for levels 2 and 3. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.

Lumipulse G CA125II Immunoreaction Cartridges For in vitro diagnostic use. Lumipulse G CA125II is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of CA125 in human serum and plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMIPULSE G System. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with ovarian cancer. Serial testing for patient CA125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. Lumipulse G CA125II Calibrators Lumipulse G CA125II Calibrators are for use in the calibration of the LUMIPULSE G System for the quantitative measurement of CA125 in human serum or plasma (sodium heparin, or dipotassium EDTA). LUMIPULSE G1200 System LUMIPULSE G1200 is intended for in vitro diagnostics use, and is designed to perform automated chemiluminescence immunoassays of specimens using Lumipulse G reagents, conducting various processes such as dispensing, agitation and photometric measurement.

Lumipulse G CA125Il is an assay system, including a set of immunoassay reagents, for the quantitative measurement of CA125 in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System. Lumipulse G CA125II Immunoreaction Cartridges consists of 3 x 14 tests. Each kit contains Antibody-Coated Particle Solution and Enzyme-Labeled Antibody Solution. Lumipulse G CA125II Calibrators Each calibrator kit contains one bottle each of Calibrators 1 and 2. The calibrator kit is packaged separately. LUMIPULSE G1200 System LUMIPULSE G1200 is intended for in vitro diagnostics use, and is designed to perform automated chemiluminescence immunoassays of specimens using Lumipulse G reagents, conducting various processes such as dispensing, agitation, and photometric measurement. The chemiluminescent enzvme immunoassay system is carried out using the ferrite particle coated with antigen or antibody and conjugate with alkaline phosphatase and the chemical luminescent substrate. The luminescence which is produced by the chemiluminescent enzyme immunoassay is measured by photometric detector.

The LOCI CA 125 II™ method is an in vitro diagnostic test for the quantitative measurement of CA 125 antigen in human serum and lithium heparin and EDTA plasma on the Dimension Vista® System. Measurements of CA 125 are used as an aid in monitoring disease progress or response to therapy or for the recurrent or residual disease for patients with epithelial ovarian cancer. Serial testing for patient CA 125 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. It is recommended that the LOCI CA 125 Il method be used in conjunction with signs and symptoms of a clinical evaluation by a physician trained and experienced in the management of gynecological cancers. This assay is not intended for screening or diagnosis of ovarian cancer or for use on any other system. The LOCI 6 CAL is an in vitro diagnostic product for the calibration of Alpha-Fetoprotein (AFP), Carcinocmbryonic Antigen (CEA), and CA 125 (CA125) methods on the Dimension Vista® System.

The LOCI CA 125Il™ method is a homogeneous, sandwich chemiluminescent immunoassay based on LOCI® technology. The LOCI® reagents include two synthetic bead reagents and a biotinylated anti-CA 125 monoclonal antibody (M11) fragment. The first bead reagent (Chemibeads) is coated with an anti-CA125 monoclonal antibody (OC 125) and contains a chemiluminescent dye. The use of the M11 antibody in combination with OC 125 defines this method as a second generation CA 125 assay. The second bead reagent (Sensibeads) is coated with streptavidin and contains a photosensitizer dye. Sample is incubated with biotinylated antibody and Chemibeads to form bead-CA 125-biotinylated antibody sandwiches. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the CA 125 concentration in the sample. The LOCI 6 calibrator is a multi-analyte liquid, frozen bovine serum albumin based product containing Alpha-Fetoprotein from human cord blood, Carcinoembryonic Antigen from human cell culture and CA 125 from human cell culture. The kit consists of ten vials per level (A-E), 2.0 mL per vial. Description of the manufacturing, value assignment and stability testing process are provided in this submission report.

VIDAS® CA 15-3 is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of CA 15-3 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 15-3 is indicated for the serial measurement of CA 15-3 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with breast cancer for disease progression or response to therapy in conjunction with other clinical methods. The VIDAS CA 15-3 assay can also be used as an aid in the detection of recurrence in previously treated Stage II and III breast cancer patients.

VIDAS CA 15-3 is an automated quantitative test for use on the VIDAS instruments for the quantitative measurement of CA 15-3 levels in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 15-3 assay is indicated for the serial measurement of CA 15-3 as an aid in the monitoring of disease progression or response to therapy in patients previously diagnosed with breast cancer. The assay principle combines a two-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. It is coated with mouse monoclonal 115D8 antibodies. The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the monoclonal 115D8 antibody fixed onto the interior wall of the SPR to capture the reactive antigenic determinants present in the sample. Unbound components are eliminated during the washing steps. Alkaline phosphatase labeled monoclonal DF3 antibody (conjugate) is then incubated in the SPR where it binds with the CA 15-3 reactive antigenic determinant. Unbound conjugate is then eliminated during the washing steps. During the final detection step, the substrate (4-Methyl-umbellifery| phosphate) is cycled in and out of the SPR. The conjuqate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methy)-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of CA 15-3 reactive antigenic determinants present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.

VIDAS® CA 125 II is an automated quantitative test for use on the VIDAS instruments, for the measurement of OC 125 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 125 II is indicated for the serial measurement of OC 125 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with Stage IV (metastatic) ovarian cancer for disease progression or response to therapy. The VIDAS CA 125 II assay can also be used as an aid in the early detection of recurrence in previously treated Stage II and III ovarian cancer patients.

VIDAS® CA 125 II is an automated quantitative test for use on the VIDAS instruments, for the measurement of CA 125 reactive antigenic determinants in human serum using the ELFA technique (Enzyme Linked Fluorescent Assay). The VIDAS CA 125 II is indicated for the serial measurement of OC 125 reactive antigenic determinants as an aid in the monitoring of patients previously diagnosed with Stage IV (metastatic) ovarian cancer for disease progression or response to therapy. The VIDAS CA 125 II assay can also be used as an aid in the early detection of recurrence in previously treated Stage II and III ovarian cancer patients. CA 125 II is a registered trademark from Fujirebio Diagnostics Inc. (formerly named Centocor Diagnostics of Pennsylvania, Inc.) The assay principle combines a two-step immunoassay sandwich method with a final fluorescent detection (ELFA). The Solid Phase Receptacle (SPR), a pipette tip-like device, serves as the solid phase as well as the pipetting device for the assay. It is coated with mouse monoclonal M 11 antibodies. The other assay reagents are ready-to-use and pre-dispensed in the sealed reagent strips (STRs). The individual kit components are described in detail on the following pages. All of the assay steps are performed automatically by the instrument. The reaction medium is cycled in and out of the SPR several times. This operation enables the monoclonal M11 antibody fixed onto the interior wall of the SPR to capture the reactive antigenic determinants present in the sample. Unbound components are eliminated during the washing steps. Alkaline phosphatase labeled mouse monoclonal OC 125 antibody (conjugate) is then incubated in the SPR where it binds with the OC 125 reactive antigenic determinant. Unbound conjugate is then eliminated during the washing steps. During the final detection step, the substrate (4-Methyl-umbelliferyl phosphate) is cycled in and out of the SPR. The conjugate enzyme catalyzes the hydrolysis of this substrate into a fluorescent product (4-Methyl-umbelliferone) the fluorescence of which is measured at 450 nm. The intensity of the fluorescence is proportional to the concentration of OC 125 reactive antigenic determinants present in the sample. At the end of the assay, results are automatically calculated by the instrument in relation to the calibration curve stored in memory, and then printed out.

Immulite 2500 OM-MA: For in vitro diagnostic use with the IMMULITE 2500 Analyzer- for the quantitative measurement of CA125 antigen in human serum, as an aid in monitoring the response to therapy for patients with epithelial ovarian cancer and in detecting residual ovarian cancer in patients who have undergone first-line therapy and would be considered for diagnostic second-look procedures. Immulite Tumor Marker Controls: TMC is an assayed, serum-based, tri-level control containing analytes associated with malignancy which are commonly measured by immunoassay. It is intended strictly for in vitro use as an aid in monitoring the day-to-day performance of assays for these constituents.

The IMMULITE 2500 OM-MA Immunoassay is a solid-phase, two-site, chemiluminescent immunometric assay for use with the IMMULITE 2500 Automated Analyzer.