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510(k) Data Aggregation

    K Number
    K102338
    Device Name
    BREATHSCN PRO
    Manufacturer
    Akers Biosciences, Inc.
    Date Cleared
    2011-01-12

    (147 days)

    Product Code
    DJZ
    Regulation Number
    862.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Akers Biosciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BreathScan PRO is an in vitro medical device that quantitatively detects the presence of alcohol in the human breath. The system is used only as a screening device and is an indication of the presence of alcohol in the blood of the test subject.
    Device Description
    The BreathScan PRO is quantitative screening test for alcohol in the human breath and provides a digital readout. The BreathScan PRO consists of a selfcontained electronic analyzer to quantitatively detect the presence of alcohol in the human breath. The detection level range is from 0.00% to 0.15%. Breath Alcohol concentrations higher than 0.15% will be displayed as BAC >0.15%. The electronic Analyzer is factory pre-calibrated and is ready to use when a Detector is fully inserted into the sample port. It is a re-usable device designed for use specifically with BreathScan®PRO detectors. The detectors are disposable screening devices designed for one time use. The BreathScan®PRO Electronic Analyzer enables the user to read or interpret their BreathScan PRO Detectors charged by human breath. The system provides an indication of the possible presence of alcohol in the blood of the test subject. The detectors contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology. The Detector consists of two parts. One part is a glass capsule containing light yellow crystals that change color when exposed to alcohol vapors. The other part is a plugged, plastic tube with an opening to blow into while running the test. When the subject exhales into the tube, the fresh crystals interact with breath vapor and change color from yellow to blue green if alcohol is present. Note: The resulting color change is dependent upon the level of alcohol detected. The blow bags are re-usable and serve as a method to assure that the subject has blown through the Detector with adequate air. With the BreathScan PRO. this is required (DOT/NHTSA compliance). ABI provides these in the starter kit and as an option for future orders.
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    K Number
    K062971
    Device Name
    BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
    Manufacturer
    Akers Biosciences, Inc.
    Date Cleared
    2006-12-18

    (80 days)

    Product Code
    DJZ
    Regulation Number
    862.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Akers Biosciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Breath Alcohol Z .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are in vitro medical devices that qualitatively detect the presence of alcohol in the human breath. The test system detects equal to or greater than 0.02 percent breath alcohol. The system is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject.
    Device Description
    The Breath Alcohol 70 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System are a visual qualitative test for alcohol in the human breath. The Breath Alcohol 20 .02 Detection System and BreathScan® .02 Breath Alcohol Detection System consist of a self-contained electronic analyzer to qualitatively detect the presence of alcohol in the human breath. It is a reusable device designed for use with a specific lot of Breath Alcohol Z . 02 or BreathScan® .02 Detectors. The detectors are disposable screening devices designed for one time use. The Breath Alcohol .02 and BreathScan .02 Electronic Analyzers enable the user to read or interpret their Breath Alcohol 70 .02 or BreathScan® .02 Detectors charged by human breath. The system provides an indication of the possible presence of alcohol in the blood of the test subject. The detectors contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology (US Patent No. 4,740,475). The Detector consists of two parts. One part is a glass capsule containing light yellow crystals that change color when exposed to alcohol vapors. The other part is a plugged, plastic tube with an opening to blow into while running the test. If alcohol is present. the crystals will change from yellow to light green/blue. How many crystals turn color will depend on the cut-off of the Detector and how much alcohol is in the breath. The yellow crystals in the Detector are coated with potassium dichromate (K2Cr2O7) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cutoff of the Detector. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium suffate [Cr2(SO4)3]. The majority of crystals change from yellow to light aqua (greenish-blue/bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Detector. The blow bags are re-usable and serve as a method to assure that the subject has blown through the Detector with adequate air. With the Breath Alcohol . 02 Detection System, this is required (DOT/NHTSA compliance) and is listed as an option in the BreathScan® .02 Breath Alcohol Detection System. The Breath Alcohol Z .02 and BreathScan® .02 Electronic Analyzers are selfcontained, sealed devices where the Breath Alcohol or BreathScan® Detector charged with human breath is inserted into the device to begin the reading process. The internal make-up of the Electronic Analyzer is the same for both models. The only difference is how the detector is positioned or inserted into the device. Using the Breath Alcohol .02 Detection System, the detector is inserted into a sample port; whereas using the BreathScan® .02 Breath Alcohol Detection System, the detector is placed in a nested holder. The Electronic Analyzer automatically turns on and the lights will flash instantaneously, indicating the respective result. The device comes pre-calibrated to the user for the cut-off sensitivity of the Breath Alcohol 700.02 or BreathScan® .02 Detector lot being "read" in the analyzer. A negative result is indicated by a continuously flashing green LED and a positive result is indicated by a continuously flashing red LED.
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    K Number
    K060761
    Device Name
    BREATHSCAN, BREATH AND BREATH CHECK ALCOHOL DETECTORS
    Manufacturer
    Akers Biosciences, Inc.
    Date Cleared
    2006-04-28

    (38 days)

    Product Code
    DJZ
    Regulation Number
    862.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Akers Biosciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BreathScan® Alcohol Detector is an in vitro medical device to qualitatively detect the presence of alcohol in the human breath. It is a disposable screening device for one-time use. The detector is available at several detection cut-offs; 0.02, 0.04, 0.05, and 0.08 percent breath alcohol. The device is used only as a screening device and is only an indication of the possible presence of alcohol in the blood of the test subject. Correlation between breath alcohol_content and blood alcohol content depends on many variables. BreathScan is not intended to legally determine blood alcohol presence, level, or inference of intoxication.
    Device Description
    The BreathScan® Alcohol Detector (Tester) is a visual qualitative test for alcohol in human breath. The Tester contains chemicals that change color in the presence of alcohol vapors) utilizing the patented technology (4,740,475). The Tester is made up of a 2-part glass vessel inside a plastic tube. One part contains light yellow crystals that change color when exposed to alcohol vapors. The other part is an opening to blow into while running the test. If alcohol is present, the crystals will change from yellow to light green/blue. How many crystals turn color will depend on the cut-off of the Tester and how much alcohol is in the breath. The yellow crystals in the Tester are coated with potassium dichromate (K)Cr30-) and sulfuric acid (H2SO4). The amount of these indicator chemicals is adjusted according to the selected cutoff of the Tester. A color change is produced when alcohol vapors are oxidized to acetic acid and the indicator chemicals change to chromium sulfate [Cr2(SO4)3]. The majority of crystals change from vellow to light aqua (greenish-bluish-green) when alcohol vapors are present at a level equal to or exceeding the cutoff of the Tester. The BreathScan® Tester is available in several cut-offs (.02%, .04%, .05%, and .08%). The cut-off is printed on the Tester label and is expressed as a specific percentage of breath alcohol.
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    K Number
    K052697
    Device Name
    HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
    Manufacturer
    Akers Biosciences, Inc.
    Date Cleared
    2006-01-04

    (98 days)

    Product Code
    GGN
    Regulation Number
    864.5425
    Why did this record match?
    Applicant Name (Manufacturer) :

    Akers Biosciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Heparin/Platelet Factor 4 Antibody Serum Panel is an assayed control, intended for use as a serum QC control to monitor and evaluate precision and accuracy of the (qualitative) PIFA® Heparin/PF4 Antibody Assay. Included are both confirmed positive and negative control panel members. The panel members enable the users to evaluate their PIFA® Heparin/PF4 Antibody Assay test systems and provide comprehensive data for comparative analysis.
    Device Description
    The Heparin/Platelet Factor 4 Antibody Serum Panel is a well-qualified serum sample identified as a positive or negative sample against the PIFA® Heparin/Platelet Factor 4 Antibody Assay. The panels are assembled from its repository of frozen serum samples, with reactivity as determined by the (FDA cleared) GTT® PF4 ENHANCED® ELISA Assay test currently available within the United States. No preservatives are added. Samples are chosen to provide a broad range of reactivity and to include samples with low antibody levels and samples with high antibody levels. A "positive" identified serum panel has OD values greater than 0.400 as determined on the GTT® PF4 ENHANCED® ELISA Assay test. Two types of kit configurations are available, specifically for use on the PIFA ® Heparin/Platelet Factor 4 Antibody Assay test systems: 2 Member QC Panel (1 positive and 1 negative sera) and Multi-Member Qualification Panel (either a 12-Member (10 positive and 2 negative sera) or 6-Member (5 positive and 1 negative sera)). All panel member vials each contain approximately 150 ul in total volume.
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    K Number
    K050338
    Device Name
    MODIFICATION TO: INSTAREAD LITHIUM SYSTEM
    Manufacturer
    Akers Biosciences, Inc.
    Date Cleared
    2005-03-04

    (21 days)

    Product Code
    JIH
    Regulation Number
    862.3560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Akers Biosciences, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The InstaRead™ Lithium System is intended to measure lithium blood levels in whole blood (fingerstick or venous). Measurements of lithium are used to aid in the management of individuals taking lithium for the treatment of mental disturbances, such as manic-depressive illness (bipolar disorder).
    Device Description
    Not Found
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