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510(k) Data Aggregation
(87 days)
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(257 days)
The Access BNP II test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications:
- as an aid in the diagnosis of heart failure (HF) in patients presenting to the emergency department (ED) with clinical suspicion of new onset, acutely decompensated, or exacerbated heart failure
- for the risk stratification of patients with acute coronary syndromes
- for the risk stratification of patients with heart failure
The Access BNP II assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of B-type natriuretic peptide (BNP) levels in human EDTA plasma using the Access Immunoassay Systems.
The Access BNP Calibrators are intended to calibrate the Access BNP and Access BNP II tests for the quantitative determination of BNP levels in human EDTA plasma using the Beckman Coulter Access Family of Immunoassay Systems.
The Access BNP II test is a two-site immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel with mouse monoclonal anti-human BNP antibody-alkaline phosphatase conjugate and paramagnetic particles coated with mouse Omniclonal anti-human BNP antibody. BNP in human plasma binds to the immobilized anti-BNP on the solid phase, while the mouse anti-BNP conjugate reacts specifically with bound BNP.
After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is inversely proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
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(256 days)
• BD Vacutainer® Plasma Separator Tubes (PST™)
The BD Vacutainer® Plasma Separator Tubes (PST™) are evacuated, sterile, single-use, in vitro diagnostic medical devices. They are intended to be used by healthcare professionals for the collection, containment, and transport of human venous blood specimens, and the subsequent separation and storage of plasma for in vitro diagnostic testing.
BD Vacutainer® Plasma Separator Tubes (PST™) are used for testing chemistry analytes in plasma samples.
• BD Vacutainer® Sodium Heparin Blood Collection Tubes
The BD Vacutainer® Sodium Heparin Blood Collection Tube is a sterile, single-use, in vitro diagnostic medical device for the collection, containment, transport of human venous blood specimens, and the subsequent separation of plasma by centrifugation, for in vitro diagnostic testing. It is used in settings where a venous blood specimen is collected by a healthcare professional.
The BD Vacutainer® Sodium Heparin Blood Collection Tube is used for testing lithium.
BD Vacutainer® Plasma Separator Tubes (PST™) and BD Vacutainer® Sodium Heparin Blood Collection Tubes are sterile Blood Collection Tubes which use a controlled vacuum to pull a specific volume of blood into the tube. Each BD Vacutainer® Plasma Separator Tube (PST™) and BD Vacutainer® Sodium Heparin Blood Collection Tube consists of 1) a plastic tube manufactured from PET (polyethylene terephthalate), 2) a BD Hemogard™ cap assembly or Conventional rubber stopper with lubricant, and 3) a spray-dried anti-coagulated formulated from lithium or sodium heparin. The BD Vacutainer® Plasma Separator Tubes (PST™) additionally include an inert polymer separator gel.
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(108 days)
The MiniMed Flex pump is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
The MiniMed Flex pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
The MiniMed Flex pump is indicated for use in persons 7 years of age and older.
The MiniMed Flex pump is intended for single patient use and requires a prescription.
The MiniMed Flex pump is an alternate controller enabled (ACE) pump intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. It can reliably and securely communicate with compatible digitally connected devices, including an integrated continuous glucose monitor (iCGM), interoperable Medtronic continuous glucose monitor (CGM), and interoperable automated glycemic controller (iAGC). The MiniMed Flex pump is intended to be used in conjunction with compatible, digitally connected medical devices (i.e., iAGC and CGM) for the purpose of drug delivery. The MiniMed Flex pump is provided with compatible iAGCs installed, refer to the compatible iAGCs for indications related to iAGC use with MiniMed Flex pump.
The MiniMed Flex pump is an ambulatory, battery-operated, rate-programmable micro-infusion pump. It is a screenless, tubed pump that houses electronics, a pumping mechanism, and a medication reservoir within the same physical device. It is intended for use with compatible insulin reservoir and insulin infusion set for delivery of basal and bolus insulin according to settings selected or inputs entered by the user or compatible iAGC software based on healthcare provider recommendations.
The MiniMed Flex pump is an interoperable device that communicates via a Bluetooth Low Energy (BLE) wireless electronic interface with digitally connected devices. The MiniMed Flex pump is able to integrate the compatible MiniMed iAGC algorithms into the pump firmware to receive, execute, and confirm commands from an iAGC to adjust delivery of insulin. The pump receives sensor glucose (SG) data from a compatible iCGM or a compatible interoperable Medtronic CGM via BLE and transmits the SG and other CGM data to the iAGCs.
The MiniMed Flex pump is a screenless pump with minimal user interface and manual control capabilities available from the pump itself. The primary user interface and primary display for the MiniMed Flex pump is the MiniMed app, also the user interface for the compatible MiniMed iAGCs, which runs on a compatible iOS or Android device.
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(245 days)
The Atellica CH Diazo Total Bilirubin (D_TBil) assay is for in vitro diagnostic use in the quantitative determination of total bilirubin in human serum and plasma of adults and neonates using the Atellica CH Analyzer. Measurement of total bilirubin, an organic compound formed during the normal and abnormal destruction of red blood cells, is used in the diagnosis and treatment of liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gallbladder block. A total bilirubin measurement in newborn infants is intended to aid in indicating the risk of bilirubin encephalopathy (kernicterus).
Atellica CH Diazo Total Bilirubin is a photometric test using 2,4-dichloroaniline (DCA). Direct bilirubin in presence of diazotized 2,4-dichloroaniline forms a red colored azocompound in acidic solution. A specific mixture of detergents enables the determination of the total bilirubin.
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(185 days)
QSCHECK UISACR is intended for the in vitro semi-quantitative measurement of the following parameters: microalbumin and creatinine in urine specimens and for Albumin/Creatinine ratio (ACR) calculated using those values. The results may be used in conjunction with clinical evaluation as an aid in the assessment for kidney function. The system is intended for prescription use only, in clinical laboratory settings.
QSCHECK UISACR consists of urine test strips and a smartphone application. In the test strips, the color of the reagent pad that contains enzymes and chemicals is changed according to the concentration of each biomarker in the urine. After the reaction on the strips, the degree of color change is photographed and analyzed by a smartphone application, QSCHECK-app, that runs on both Apple iPhone 14 (iOS v26) and Samsung Galaxy S23 (Android v16).
The software of the QSCHECK-app. recognizes the location of the reagent pad through the QR code on the urine test strip and checks the degree of color development using RGB color codes. The RGB color codes are converted to Hue (H), Saturation (S), Value (V) color model, which is a method of expressing color or arranging colors according to this method. The results are displayed by matching colorimetric tables for each section that were previously classified according to HSV.
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(97 days)
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(111 days)
cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semiquantitative, and quantitative clinical chemistry and immunochemistry assays as well as ion-selective measurements.
Glucose HK Gen.3 is an in vitro test for the quantitative determination of glucose in human serum, plasma, urine and CSF on cobas c systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell tumors.
Methadone II (MDN2) is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on cobas c systems at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC-MS).
Methadone II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
The cobas pro integrated solutions consists of a high throughput core unit (sample supply unit and sample buffer unit) and can be configured with different analytical units for immunology, clinical chemistry, and electrolyte testing. The cobas c 703 analytical unit being added to cobas pro integrated solutions is a new clinical chemistry analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.
The Methadone assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When a urine sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle‑bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
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(111 days)
cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semiquantitative, and quantitative clinical chemistry and immunochemistry assays as well as ion-selective measurements.
Glucose HK Gen.3 is an in vitro test for the quantitative determination of glucose in human serum, plasma, urine and CSF on cobas c systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell tumors.
Methadone II (MDN2) is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on cobas c systems at a cutoff concentration of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Semiquantitative assays are intended to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as gas chromatography/mass spectrometry (GC-MS).
Methadone II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. GC-MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semiquantitative, and quantitative clinical chemistry and immunochemistry assays as well as ion-selective measurements.
The cobas pro integrated solutions consists of a high throughput core unit (sample supply unit and sample buffer unit) and can be configured with different analytical units for immunology, clinical chemistry, and electrolyte testing. The cobas c 703 analytical unit being added to cobas pro integrated solutions is a new clinical chemistry analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.
Glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) and magnesium ions to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide (NAD) to nicotinamide adenine dinucleotide reduced (NADH). One micromole of NADH is produced for each micromole of glucose consumed. The NADH produced absorbs light at 340 nm and can be detected spectrophotometrically as an increased absorbance.
The Methadone assay is based on the kinetic interaction of microparticles in a solution (KIMS) as measured by changes in light transmission. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing the formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When a urine sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle‑bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.
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(262 days)
The Atellica® IM TSH3‑Ultra II (TSH3ULII) assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH, thyrotropin) in human serum and plasma (EDTA and lithium heparin) using the Atellica® IM Analyzer. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.
This assay is a third-generation assay that employs anti-FITC monoclonal antibody covalently bound to paramagnetic particles, an FITC-labeled anti-TSH capture mouse monoclonal antibody, and a tracer consisting of a proprietary acridinium ester and an anti‑TSH mouse monoclonal antibody conjugated to bovine serum albumin (BSA) for chemiluminescent detection.
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