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510(k) Data Aggregation

    K Number
    K221326
    Device Name
    Nova Allegro HbA1c Assay, Nova Allegro Analyzer
    Manufacturer
    Nova Biomedical Corporation
    Date Cleared
    2024-11-22

    (931 days)

    Product Code
    LCP, JQT
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K231465
    Device Name
    Q-Pad Test System
    Manufacturer
    Qurasense
    Date Cleared
    2023-12-06

    (201 days)

    Product Code
    LCP, QZG
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K214117
    Device Name
    Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer
    Manufacturer
    Abbott Diagnostics Technologies AS
    Date Cleared
    2023-09-27

    (636 days)

    Product Code
    LCP, JQT
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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,
    Device Description
    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.
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    K Number
    K192987
    Device Name
    Aina HbA1c Monitoring System 2
    Manufacturer
    Jana Care, Inc
    Date Cleared
    2020-03-26

    (153 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K192369
    Device Name
    PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
    Manufacturer
    iXensor Co. Ltd.
    Date Cleared
    2019-10-29

    (60 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    Not Found
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    K Number
    K183230
    Device Name
    OneDraw A1C Test System
    Manufacturer
    Drawbridge Health, Inc.
    Date Cleared
    2019-08-15

    (268 days)

    Product Code
    LCP, PRJ
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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.
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    K Number
    K181915
    Device Name
    PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit
    Manufacturer
    iXensor Co., LTD.
    Date Cleared
    2019-04-12

    (269 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    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.
    Device Description
    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
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    K Number
    K180509
    Device Name
    Quo-Test A1c System
    Manufacturer
    EKF-diagnostic GmbH
    Date Cleared
    2019-02-16

    (354 days)

    Product Code
    LCP, JJE
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Quo-Test Alc System is intended for the in vitro quantitative determination of glycated hemoglobin (%HbA1c) levels in venous whole blood samples (using K2EDTA and lithium heparin anticoagulants). Measurement of percent glycated hemoglobin (%HbA1c) is effective for monitoring long-term glycemic control in individuals previously diagnosed with diabetes mellitus. The Quo-Test A1c System is not intended for screening or diagnosis of diabetes or neonatal use. The device is intended for professional use in a clinical laboratory setting.
    Device Description
    The Quo-Test Analyzer and A1c Test Kit (Quo-Test A1c System) are intended for the in-vitro quantitative determination of glycated hemoglobin in whole blood samples obtained from venous samples. The system contains a fluorimeter and two photometers to enable both fluorescent and photometric measurements to be made. The Quo-Test A1C Assay is calibrated by the manufacturer using European Reference Laboratory (ERL) calibrators. There are no user-serviceable parts in the analyzer. It has ports to support a printer and barcode scanner plus a USB port. It is powered by an AC/DC adapter plugged into a 100-240V AC outlet. The Quo-Test A1c Test Cartridge contains all the reagents, in a plastic cuvette, required to perform an HbA1c test on the Quo-Test Analyzer. The reagents consist of a lysing agent, buffer and a boronate fluorophore conjugate. A low level of sodium azide preservative is used to enhance the shelf life of the test cartridge. Each test cartridge is for single-use. The test cartridges are supplied in individual foil pouches and should be stored at 2 - 8°C.
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    K Number
    K173127
    Device Name
    skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit)
    Manufacturer
    Skyla Corporation H.S.P.B.
    Date Cleared
    2018-09-25

    (361 days)

    Product Code
    LCP, JJE
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The skyla Hi Hemoglobin A1c System, consisting of the skyla Hi Analyzer and skyla Hi Hemoglobin A1c Reagent Kit is an in-vitro diagnostic test for quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA Ic %) in venous and finger-stick capillary whole blood. The measurement of % HbA1c is used to monitor long-term glycemic control in persons previously diagnosed with diabetes mellitus. This system is intended for clinical laboratory and point-of-care use. This test is not for screening or diagnosis of diabetes.
    Device Description
    The skyla Hi Analyzer is a portable and compact system, and was designed with skyla Hi Hemoglobin A1c Reagent Kit for on-site quantitative measurement of the percent concentration (%) of glycated hemoglobin (HbA1c %) in human blood.
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    K Number
    K170623
    Device Name
    ACE Hemoglobin A1c (HbA1c) Reagent
    Manufacturer
    ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC
    Date Cleared
    2018-02-27

    (363 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Why did this record match?
    Product Code :

    LCP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ACE Hemoglobin A lc (HbA lc) Reagent is intended for the quantitative determination of percent hemoglobin A lc in venous whole blood collected in K2-EDTA tubes using the ACE Axcel® Clinical Chemistry Systems. This test is intended for use in clinical laboratories and physician office laboratories to monitor long term blood glucose control in individuals with diabetes mellitus. For in vitro diagnostic use only.
    Device Description
    The ACE Hemoglobin A1c (HbA1c) Reagent assay requires a pretreatment step of denaturation of the whole blood samples, which is performed off-line. The red blood cells in the sample are lysed by the Hemoglobin Denaturant and the hemoglobin chains are hydrolyzed. For determination of HbA1c, a latex agglutination inhibition assay is used. In the absence of HbA1c in the sample, the synthetic polymer containing the immunoreactive portion of HbA 1c Agglutinator Reagent will agglutinate with the antibody-coated microparticles in the HbA1c Antibody Reagent. The presence of HbA1c in the blood sample competes for the antibody binding sites and inhibits agglutination. The increase in absorbance, monochromatically at 692 mm, is inversely proportional to the HbA1c present in the sample. For the determination of total hemoglobin, all hemoglobin derivatives in the sample are converted to alkaline hematin. The reaction produces a green colored solution. which is measured bichromatically at 573 nm/692 nm. The intensity of color produced is directly proportional to the total hemoglobin concentration in the sample. The concentrations of both HbA 1 c and total hemoglobin are measured, the ratio is calculated, and the result reported as percent HbA1c.
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