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BioSieve™ Fentanyl FIA Home Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. BioSieve™ Fentanyl FIA Pro Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader. It is for in vitro diagnostic use only. The tests provide only preliminary results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive. BioSieve™ Toxismart Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader is intended for OTC use.

BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentanyl FIA Pro Test Kit are immunoassays intended for the qualitative detection of fentanyl in human urine. These candidate test kits are the same physical devices as the predicate device cleared in K240124. Each BioSieve™ Fentanyl Test Kit consists of a test cassette and a package insert. Each test cassette is sealed with sachets of desiccant in an aluminum pouch. BioSieve™ Toxismart Reader is a portable fluorescence instrument that is intended for use with the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentany] Pro Test Kit. The Reader scans the test cassettes included in the Test Kits and displays the results.

BioSieve™ Fentanyl FIA Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ ToxiSmart FIA Reader. It is for in vitro diagnostic use only. It is intended for prescription use. The tests provide only preliminary results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive. BioSieve™ ToxiSmart FIA Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader can be used in a laboratory or in a point-of-care setting.

This test uses a lateral flow design with location-dependent lines and zones. BioSieve™ ToxiSmart FIA Reader scans the test strip and displays results. The sample is added to the sample well of the test card, and the sample is drawn by capillary action into and through the fluorescent labeled pad, through the nitrocellulose strip and into the adsorption pad. Within the fluorescent labeled pad, the specimen comes into contact with antibodies conjugated with fluorescent microspheres. During this interaction, if the amount of fentanyl antigen in the sample is greater than or equal to the cutoff value, the antigen in the sample and the fluorescence-labeled antibody bind to the FTY antigenantibody complex when the sample passes through a pad of fluorescence-microbead-labeled antibody conjugate. As the sample flows and reaches the FTY antigen coated by the T-line of nitrocellulose membrane, the FTY antigen coated by the T-line antigen in the sample competitively bind the FTY antibody labeled with fluorescence, then the T-line captures fluorescence signal is weaker than the cutoff fluorescence signal. When the samples do not contain fentanyl antigen or levels below the cutoff value, as the sample flow, fluorescent microsphere labeled antibody to nitrocellulose membrane T line captures fluorescent signal is stronger than the cutoff fluorescence signal. Whether or not FTY antigen was present in the sample, the rabbit IgG fluorescent microsphere conjugate not bound to the test line continued to flow with the rest of the sample and soon encountered a control line composed of goatanti-rabbit IgG. The position of C-line will accumulate fluorescence signal. The C-line control area was scanned to confirm that adequate sample flow had occurred. High resolution, narrow band SMD LED was used as light source in the Immunofluorescence Analyzer. The central wavelength of the excitation spectrum is 365nm. The central response wavelength is 610nm.

The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Superbio Immunofluorescence Analyzer EASY-11. This in vitro diagnostic device is for prescription use only. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

This test uses a lateral flow design with location-dependent lines and zones. The Immunofluorescence Analyzer EASY-11 scans the test strip and displays results. The sample is added to the sample well of the test card, and the sample is drawn by capillary action into and through the fluorescent labeled pad, through the nitrocellulose strip and into the adsorption pad. Within the fluorescent labeled pad, the specimen comes into contact with antibodies conjugated with fluorescent microspheres. During this interaction, if the amount of fentanyl antigen in the sample is greater than or equal to the detection limit, the antigen in the sample and the fluorescence-labeled antibody bind to the FTY antigen-antibody complex when the sample passes through a pad of fluorescence-microbead-labeled antibody conjugate. As the sample flows and reaches the FTY antigen coated by the T-line of nitrocellulose membrane, the FTY antigen coated by the T-line and the antigen in the sample competitively bind the FTY antibody labeled with fluorescence, then the T-line captures no fluorescence signal. When the samples do not contain fentanyl antigen or levels below the detection limit, as the sample flow, fluorescent microsphere labeled antibody to nitrocellulose membrane T line captures fluorescent signal. Whether or not FTY antigen was present in the sample, the rabbit IgG fluorescent microsphere conjugate not bound to the test line continued to flow with the rest of the sample and soon encountered a control line composed of sheep antirabbit IgG. The position of C-line will accumulate fluorescence signal. The C-line control area was scanned to confirm that adequate sample flow had occurred. High resolution, narrow band SMD LED was used as light source in the Immunofluorescence Analyzer. The central wavelength of the excitation spectrum is 365nm. The central response wavelength is 610nm.

The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below: | Abbreviation | Analyte | Calibrator | Cutoff | |--------------|---------------------------|-------------------------|------------| | AMP | Amphetamines | d-Amphetamine | 500 ng/mL | | mAMP | Methamphetamines | d-Methamphetamine | 500 ng/mL | | BAR | Barbiturates | Butalbital | 200 ng/mL | | BZO | Benzodiazepines | Temazepam | 200 ng/mL | | COC | Cocaine | Benzoylecgonine | 150 ng/mL | | EDDP | Methadone Metabolite | EDDP | 100 ng/mL | | OPI | Opiates | Morphine | 300 ng/mL | | THC | Cannabinoids | 11-nor-9-carboxy-Δ9-THC | 50 ng/mL | | TCA | Tricyclic Antidepressants | Desipramine | 1000 ng/mL | This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. Quidel Triage® MeterPro: The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.

Quidel Triage® TOX Drug Screen, 94600: The Quidel Triage® TOX Drug Screen, 94600 is a single use test device and is used in conjunction with the Quidel Triage® MeterPro. The device contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result. Quidel Triage® MeterPro: The Quidel Triage MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage MeterPro can be used in a laboratory or in a point-of-care setting. The Quidel Triage MeterPro uses a laser as a light source. Light from the laser hits a test device that has been inserted in the meter. This causes the fluorescent dye in the test device to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.

The Sofia Strep A+ FIA detects Group A Streptococcal antigens from patients with signs and symptoms of pharyngitis, such as sore throat. All negative test results should be confirmed by either bacterial culture or an FDA-cleared molecular assay because negative results do not prection and should not be used as the sole basis for treatment. The test is intended for professional and laboratory use as an aid in the diagnosis of Group A Streptococcal infection. The Sofia Strep A+ FIA may be used with Sofia or Sofia 2.

The Sofia Strep A+ FIA involves the extraction of the antigenic components of the Group A Streptococcus (GAS) bacteria. The patient's Swab sample is placed in the Reagent Tube containing the Reagent Solution, during which time the bacterial antigens are extracted, making them more accessible to the specific antibodies. An aliquot of the extracted sample is dispensed into the Test Cassette sample well. From the sample well, the sample migrates through a test strip containing various unique chemical environments. If Group A Streptococcal antigens are present, they will be bound by antibodies coupled to fluorescent microparticles that migrate through the test strip. The fluorescent microparticles containing bound antigen will be captured by antibodies at a defined location on the test strip where they are detected by Sofia or Sofia 2. If antigens are not present, the fluorescent microparticles will not be trapped by the capture antibodies nor detected by Sofia or Sofia 2. Depending upon the user's choice, the Test Cassette is either placed inside of Sofia or Sofia 2 for automatically timed development (WALK AWAY Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (READ NOW Mode). Sofia or Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Test results will be displayed (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected. Sofia 2 is a microprocessor-controlled device about the size of a desk top telephone and weighs less than 3 pounds. Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results.

The CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction. The Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium heparin whole-blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the rapid diagnosis of heart disease, for example, acute myocardial infarction. For in vitro diagnostic use. The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

The AQT90 FLEX is a cartridge-based immunoassay analyzer, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample. This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups – no liquids other than the sample itself together with the assay buffer are required.

The Sofia RSV FIA employs immunofluorescence for detection of respiratory syncytial virus (RSV) nucleoprotein antigen in nasopharyngeal swab and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients. This qualitative test is intended for use as an aid in the rapid diagnosis of acute RSV infections in pediatric patients. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative result is presumptive, and it is recommended these results be confirmed by viral culture or an FDA-cleared RSV molecular assay. The Sofia RSV FIA may be used with the Sofia or Sofia 2.

The Sofia RSV FIA test employs immunofluorescence technology that is used with Sofia for the rapid detection of RSV antigens. The Sofia RSV FIA test involves the disruption of RSV viral antigens. The patient specimen is placed in the Reagent Tube, during which time the virus particles in the specimen are disrupted, exposing internal viral nucleoproteins. After disruption, the specimen is dispensed into the Cassette sample well. From the sample well, the specimen migrates through a test strip containing various unique chemical environments. If RSV viral antigens are present, they will be trapped in a specific location. Note: Depending upon the user's choice, the cassette is either placed inside of Sofia or Sofia 2 for automatically timed development (Walk Away Mode) or placed on the counter or bench top for a manually timed development and then placed into Sofia 2 to be scanned (Read Now Mode). Sofia or Sofia 2 will scan the test strip and measure the fluorescent signal by processing the results using method-specific algorithms. Test results will be displayed (Positive, or Invalid) on the screen. The results can also be automatically printed on an integrated printer if this option is selected. Sofia 2 is a microprocessor-controlled device about the size of a desk top telephone and weighs less than 3 pounds. Sofia 2 uses a fluorescent tag that is illuminated by an Ultraviolet (UV) light source to generate specific results.

The FREND™ PSA Plus as performed on the FREND™ system, is a quantitative in vitro diagnostic test which measures total Prostate Specific Antigen (PSA) in human serum and plasma. The NanoEnTek FREND™ PSA Plus is designed for in vitro DIAGNOSTIC USE ONL Y for the quantitative measurement of total Prostate Specific Antigen (PSA) in human serum, heparinized plasma, and EDTA plasma using the FREND™ System. This device is indicated for the serial measurement of total PSA in serum, heparinized plasma and EDTA plasma to be used as an aid in the management of patients with prostate cancer. The FREND™ PSA Plus is indicated for use in clinical laboratories upon prescription by the attending physician as an aid to clinicians in managing patients with prostate cancer. The information provided from this test may supplement decision-making and should only be used in conjunction with routine monitoring by a physician and the use of other diagnostic procedures. Because of the variability in the effects of various medications used in the treatment of prostate cancer, clinicians should use professional judgment in the interpretation of PSA results as an indicator of disease status.

The FREND™ PSA Plus is a rapid fluorescence immunoassay that measures prostate specific antigen (PSA) in human serum and in lithium heparin and EDTA plasma using the FREND™ system. The FREND™ PSA Plus is intended for use as an aid for prostate cancer management. The FREND™ PSA Plus Test is a single use fluorescence immunoassay designed to quantify the concentration of total PSA in serum and lithium heparin and EDTA plasma samples. The specimen is added by the operator to the sample inlet with a transfer pipet, allowing the appropriate volume of sample (30 µL) to be delivered into the FREND™ PSA Plus Test Cartridge. The Cartridge is then placed into the FREND™ System, which is programmed to begin analysis once the sample has reacted with the reagents. The reaction and analysis time is approximately 6 minutes. The PSA quantification is based on the amount of fluorescence detected by the FREND™ System at the FREND™ PSA Plus Test Cartridge window. A higher level of fluorescence is indicative of a higher PSA concentration. In other words, the magnitude of the fluorescent signal is directly proportional to the amount of total PSA in the sample. The FREND™ System is a bench top fluorescence reader containing a touchscreen user interface. The System has a slot that accepts the FREND™ PSA Plus Test Cartridge (which contains the reagents and sample), and is programmed to analyze the Test when the sample has fully reacted with the on-board in cartridge reagents. Results of the test are displayed on the screen and can be printed on an optional printer through the RS232C interface.

AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings. AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction. AOT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer. AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.

The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample. This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.

This kit is intended for the quantitative determination of human thyroid stimulating hormone (hTSH) in blood specimens dried on filter paper as an aid in screening newborns for congenital (neonatal) hypothyroidism using the GSP instrument. The GSPTM Instrument is a fully automated, high throughput batch analyzer for time resolved analysis of samples in microtitration plates. It is in intended for in vitro quantitative / qualitative determination of analytes in body fluids.

The GSP instrument (genetic screening processor) is a fully automated, high throughput batch analyzer for timeresolved and prompt fluorescence analysis of samples in microtitration plates. It is intended for in vitro quantitative and qualitative determination of analytes in body fluids. The GSP instrument and GSP chemistries are for professional use only. The GSPTM Neonatal hTSH assay is a solid phase, twosite fluoroimmunometric assay based on the direct sandwich technique in which two monoclonal antibodies (derived from mice) are directed against two separate antigenic determinants on the hTSH molecule. Calibrators, controls and test specimens containing hTSH are reacted simultaneously with immobilized monoclonal antibodies directed against a specific antigenic site on the ß hTSH subunit and europium-labeled monoclonal antibodies (directed against a different antigenic site located partly on the B subunit and partly on the a subunit) in assay buffer. The assay buffer elutes hTSH from the dried blood spots on the filter paper disks. The complete assay requires only one incubation step. DELFIA Inducer dissociates europium ions from the labeled antibody 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 proportional to the concentration of hTSH in the sample.