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The Nova Allegro HbA1c Assay is intended for in vitro diagnostic use on the Nova Allegro Analyzer for the quantitative determination of the glycated Hemoglobin A1c) in capillary whole blood obtained from the fingertip. The results from this assay are intended to be used for the monitoring of long-term blood glucose/metabolic control in individuals with diabetes mellitus. The Nova Allegro Analyzer is intended for in vitro diagnostic use in clinical laboratory and near-patient testing (point-of-care) settings for the quantitative determination of Nova Allegro Assays using Nova Allegro Test Cartridges.

Nova Allegro Analyzer: The Nova Allegro Analyzer is a compact, point-of-care analyzer that features a clinically important menu of measured and calculated tests. All tests are measured with disposable, ready-to-use cartridges, and are easily performed by non-technical personnel. The analyzer supports multiple wavelengths that are used to measure the assay of interest. The analyzer consists of the following key systems/components that the user interacts with: Two analytical bays where the single use test cartridges are analyzed, Color Touchscreen Display, Barcode Scanner, Printer, Data Export Options, Ethernet Connection, USB Port. Nova Allegro HbA1c Assay: The Allegro HbA1c Assay is a completely automated assay for the HbA1c in human whole blood and the calculation of estimated average glucose (eAG). Nova Allegro HbA1c Test Cartridges are the key element a user interacts with to obtain the HbA1c concentration in a Capillary finger-stick whole blood sample. The main components of the Test Cartridge are the Capillary that is used to obtain the Capillary finger-stick whole blood specimen and present it to the Test Cartridge and the reaction chamber. The Test Cartridge has a barcode label with lot specific information.

The O-Pad Test System is comprised of the O-Pad Kit and the O-Pad A1c Test. The Q-Pad Kit is an in vitro diagnostic specimen collection and storage device intended for the collection of menstrual blood samples by individuals 18 years and older for subsequent analysis by an assay validated for use with the Q-Pad menstrual pad. The Q-Pad A1c Test is an in vitro diagnostic device for the quantitative measurement of Hemoglobin A1C using menstrual whole blood collected onto filter paper using the Q-Pad A1c Test is for the measurement of HbA I c on whole menstrual blood which will be self-collected by lay users at home and shipped to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in women with diabetes. This test is not to be used to diagnose or screen for diabetes.

The Q-Pad Test System consists of the Q-Pad Kit and the Q-Pad A1c Test. The Q-Pad Kit is an in vitro diagnostic specimen collection and storage device intended for the collection of menstrual blood samples. The Q-Pad A1c Test is an in vitro diagnostic device for the quantitative measurement of Hemoglobin A1C using menstrual whole blood collected onto filter paper using the Q-Pad Kit. The Q-Pad menstrual pad (also referred to as "Q-Pad") is a modified menstrual pad which looks, feels, and is used like a normal menstrual pad. The Q-Pad has an embedded blood collection strip (Q-Strip) which can easily be removed and shipped for analysis at a laboratory. Instructions for use and results are presented in a HIPAA compliant mobile application.

Afinion™ HbA1c is an in vitro diagnostic test for quantitative determination of glycated hemoglobin (1c, HbA1c) in venous and capillary human whole blood. The measurement of % HbA1c is recommended as a marker of longterm metabolic control in persons with diabetes mellitus. Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ test cartridges is for in vitro diagnostic use only. Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC) is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ Test Cartridges. The ADCC is a small device for automatic transfer of data, including patient and control assay results, from the Alere Afinion™ Analyzer to a laboratory information system or another electronic journal system. Alere Afinion™ AS100 Analyzer System, consisting of Alere Afinion™ AS100 Analyzer with Alere Afinion™ Data Connectivity Converter (ADCC), Afinion™ Test Cartridges and Afinion™ Controls is for in vitro diagnostic use only,

The Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a marker of long term metabolic control in persons with diabetes mellitus. The Afinion™ HbA1c assay is designed to be used with the Afinion™ AS100 Analyzer and the Afinion™ 2 analyzer which are compact multi-assay analyzers for point-of-care testing. Quality control using the Afinion™ HbA1c Control is recommended to confirm that the system is working properly and provides reliable results.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in venous whole blood specimens using ion-exchange high-performance liquid chromatography (HPLC). This test is an aid in diagnosis of diabetes and identifying patients who may be at risk for developing diabetes, and for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is an automated High-Performance Liguid Chromatography (HPLC) system that separates and reports stable hemoglobin A1c (sA1c) percentage in venous whole blood. The operational portion of the G8 is composed of a sampling unit, liquid pump, degasser, column, detector, microprocessors, sample loader, smart media card, operation panel, and a printer. The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 uses ion-exchange HPLC for rapid, accurate, and precise separation of the stable form of HbA1c (sA1c) from other hemoglobin fractions. The G8 uses a non-porous cation exchange column and separates the hemoglobin components in the blood. Separation is achieved by utilizing differences in ionic interactions between the cation and exchange group on the column resin surface and the hemoglobin components in a step gradient elution. The hemoglobin fractions (designated as A1a. A1b. F. LA1c+, SA1c, A0, and, if present, H-V0, H-V2, H-V2 and H-V3) are subsequently removed from the column by performing a step-wise elution gradient using the varied salt concentrations in the Variant Elution Buffers HSi 1, 2 and 3. The peaks, H-V0, H-V1, H-V2 and H-V3 are typically presumptive HbAD, HbAS, HbAC and HbAE respectively. The software compares the retention times of hemoglobin fractions in a sample to the expected "windows of retention" and labels each fraction that correctly elutes within a defined expected window of retention. The software designates a hemoglobin fraction as POX (where X is the order of the peak as it elutes from the column) if it does not match a defined window of retention. All automated processes in the G8 are controlled by internal microprocessors, using software downloaded via a smart media card. The result report is printed and can be stored on the instrument. The data can be transmitted to a host computer through a bi-directional interface. The result report includes the sample ID, date, percentage and retention time of each fraction of hemoglobin, sA1c percentage and total A1 percentage, along with a chromatogram of the elution pattern of the hemoglobin fractions. If a sample contains a hemoglobin variant, the column elutes the fraction depending upon its charge.

The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay is an in vitro diagnostic assay for the quantitative determination of mmol/mol HbA1c (IFCC) and % HbA1c (DCCT/NGSP) in human anticoagulated venous whole blood and hemolysate for use on the ADVIA® Chemistry Systems. Measurement of Hemoglobin A1c is used as an aid in the diagnosis and monitoring of long-term blood glucose control in patients with diabetes mellitus, and as an aid in the identification of patients at risk for developing diabetes mellitus.

The ADVIA® Chemistry Enzymatic Hemoglobin A1c (A1c E) assay measures hemoglobin A1c in human anticoagulated whole blood and hemolysate. The assay consists of three reagents (R1, R2, and Pretreatment Solution), which are liquid and ready to use. The assay offers both an automated and a manual application. The automated application (A1c_E) lyses the anticoagulated whole blood specimen on the system for the automated application (A1c E). Samples may also be lysed manually using the ADVIA® Chemistry A1c_E Pretreatment Solution to obtain hemolysate for the manual application (A1c_EM). The two applications yield the same results.

The Aina HbA1c Monitoring System 2 consists of the Aina 2 Automated HbA1c Device, Aina HbA1c Test Kits, mobile device, and the Aina Mobile Application. It is intended to be used for quantitative measurement of % HbA1c (DCCT/NGSP) and mmol/mol HbA1c (IFCC) in human anticoagulated venous whole blood. It is intended for in-vitro diagnostic use by healthcare professionals in a laboratory environment to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not in the diagnosis of or screening for diabetes or for use on neonates.

The system consists of the Aina 2 Automated HbA1c Device for sample processing that connects to a smartphone via Bluetooth, the Aina Device for optical test strip readout, Aina HbA1c Test Kits which contain all the reagents necessary for running each HbA1c test, and the Aina Mobile Application. The Aina Device is a reflectance-based colorimetric sensor device that connects to the mobile device through the audio jack. The smartphone runs the Aina Mobile Application, which is software that allows for user interaction and illustrates the step-by-step testing process on its touchscreen. The Aina Mobile Application software is responsible for analyzing the optical signals measured by and transferred to it by the Aina Device, including applying analysis algorithms to compute the HbA1c reading. In addition, the Aina Mobile Application controls the functioning of the Aina 2 Automated HbA1c Device by sending it commands via Bluetooth. Streck A1c-Cellular control solutions can be used for regular quality control checking of the system.

The Tina-quant Hemoglobin A1cDx Gen.3 assay is intended for use as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or venous whole blood on the cobas c 503 clinical chemistry analyzer. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Tina-quant Hemoglobin A1cDx Gen.3 assay is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the cobas c 503 clinical chemistry analyzer. The assay offers separate applications that are specific to the sample types whole blood and hemolysate. The Whole Blood Application differs from the Hemolysate Application in the hemolyzing step. For the Whole Blood Application, whole blood samples are placed on the analyzer and hemolysis occurs onboard the analyzer. For the Hemolysate Application, hemolyzed samples are placed on the analyzer and hemolysis occurs manually before placing the samples onboard the analyzer. The two applications yield the same results. Hemolyzing reagent is part of the test system and is either placed on board the analyzer for the Whole Blood Application or used manually for the Hemolysate Application. Anticoagulated whole blood is hemolyzed either manually or automatically prior to determination of HbAlc by a turbidimetric inhibition immunoassay. Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbAlc from the HbAlc/Hb ratio according to a user selected protocol, either IFCC or NGSP protocols.

The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in fingerstick capillary and venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus. The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.

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The OneDraw™ A1C Test System, which consists of the OneDraw Blood Collection Device and the OneDraw A1C Test, is intended to collect capillary blood from the upper arm of individuals 18 years of age or older onto filter (matrix) paper within the collection device by a healthcare professional. Samples are delivered to the laboratory for the quantitative measurement of HbA1c for monitoring the long-term control of blood sugar (glucose) in people with diabetes. Testing performed on samples collected with this device should not be used to diagnose or screen for diabetes. The OneDraw A1C Test System should not be used with neonates.

The OneDraw™ A1C Test System includes the OneDraw Blood Collection Device and the OneDraw A 1C Test. The OneDraw Blood Collection Device is a single-use, sterile, capillary blood specimen collection device. The OneDraw Blood Collection Device includes a transport sleeve, accessories, and instructions (OneDraw Blood Collection Device Instructions for Use (IFU)) which are needed to collect, package, and mail the sample to the designated certified clinical laboratory for HbA1c testing, using the OneDraw A1C Test. The OneDraw Blood Collection Device incorporates lancets to make incisions in the skin and a vacuum to draw blood at the surface of the skin through channels to deposit the blood onto collection and stabilization matrices (matrix strips). The matrix strips are contained within a cartridge which is removed from the device after the draw is complete. The cartridge is then inserted into the transport sleeve which encloses and protects the sample during shipping to the clinical laboratory. Once the transport sleeve containing the sample is received by the clinical laboratory, one of the dry blood sample matrices is removed. The matrix is then eluted in Beckman Hemolyzing Reagent (BHR) in 2 mL tubes or 2.2 mL deepwell plates using an orbital shaker. Next, the sample is diluted in BHR to its final concentration and tested using FDA-cleared Beckman Coulter AU480 Chemistry Analyzer and A 1 c reagents, including calibrators, (K 120199) per the OneDraw A 1 C Test IFU.

The PixoTest POCT System, consisting of PixoTest POCT Analyzer and PixoTest A1c Test Kit, is used for the quantitative measurement of glycated hemoglobin (%HbA1c) in venous whole blood samples. It is an in-vitro diagnostic system intended to monitor long term glycemic control in individuals previously diagnosed with diabetes mellitus. The PixoTest POCT System is intended for clinical laboratory and Point-of-Care Professional use. It is not intended for use in the diagnosis of or screening for diabetes and is not intended for use on neonates.

PixoTest® POCT System consists of the following devices: 1) PixoTest® POCT Analyzer Include: - PixoHealth POCT A1c App - USB Charger - USB Type C Charge Cable - PixoTest POCT Calibration Card 2) PixoTest® POCT A1c Test Kit Include: - A1c Test Strip - Spoit with Latex-Tablet - Buffer Solution Tube