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510(k) Data Aggregation

    K Number
    K193556
    Device Name
    Cryocheck Hex LA
    Manufacturer
    Precision BioLogic
    Date Cleared
    2020-10-23

    (305 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CRYOcheck Hex LA is for clinical laboratory use as a qualitative test kit intended to aid in the detection of lupus anticoagulants (LA) in 3.2% citrated human plasma by the application of hexagonal phase phospholipids. CRYOcheck Hex LA should be used as an integrated test for lupus anticoagulant detection. For in vitro diagnostic use. The performance of this device has not been established in neonate and pediatric patient populations.
    Device Description
    CRYOcheck Hex LA is comprised of three reagents supplied in a frozen format as follows: LA Start: Pooled normal plasma with buffer and a heparin neutralizer. LA Correct: Pooled normal plasma with buffer, a heparin neutralizer, and inverted hexagonal phase phospholipid. LA APTT: Silica-based lupus sensitive APTT reagent with stabilizer.
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    K Number
    K160445
    Device Name
    HemosIL Silica Clotting Time
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2016-03-16

    (28 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies. For in vitro diagnostic use.
    Device Description
    The HemoIL SCT assay, consisting of SCT Screen and SCT Confirm, is intended to simplify and standardize the detection of Lupus Anticoagulants (LA) in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times. Silica Clotting Time in the presence of calcium, directly activates the intrinsic pathway of coagulation. SCT Screen and SCT Confirm are therefore unaffected by factor VII deficiencies or inhibitors.
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    K Number
    K053111
    Device Name
    STA-CEPHASCREEN KIT
    Manufacturer
    DIAGNOSTICA STAGO, INC.
    Date Cleared
    2006-05-04

    (181 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STA® - Cephascreen® kits provide reagents for the determination of the activated partial thromboplastin time (APTT) in citrated plasma on the STA® line of analyzers suitable to these reagents.
    Device Description
    The STA®-Cephascreen kits provide reagents for the determination of the activated partial thromboplastin time (APTT) according to Langdell R.D. et al. (1) and Larrieu M. J., Weilland C. (2) by analyzers of the STA® line suitable to these reagents. STA®-Cephascreen ®: reagent containing cephalin (platelet substitute), prepared from rabbit cerebral tissues (2) and a polyphenolic activator (patent pending) in a buffered medium. The STA®-Cephascreen ® is available in two different kit sizes: - STA®-Cephascreen®©(REF00308) containing 12x4 mL vials ready for . use reagent - STA®-Cephascreen®쓰(REF 00310) containing 12x10 mL vials of ready . for use reagent The STA®-Cephascreen® reagents are provided in liquid form, ready for use after stabilization and mixing when a vial is opened.
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    K Number
    K060688
    Device Name
    HEMOSIL SYNTHASIL
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2006-04-13

    (29 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems. The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
    Device Description
    HemosIL SynthASil is a high quality synthetic phospholipid reagent for the in vitro determination of Activated Partial Thromboplastin Time (APTT) in human citrated plasma on IL Coagulation and ELECTRA Systems. The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring of heparin therapy.
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    K Number
    K050221
    Device Name
    HEMOSIL SILICA CLOTTING TIME
    Manufacturer
    INSTRUMENTATION LABORATORY CO.
    Date Cleared
    2005-03-30

    (58 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies. For in vitro diagnostic use.
    Device Description
    HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.
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    K Number
    K022021
    Device Name
    VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
    Manufacturer
    VITAL SCIENTIFIC N.V.
    Date Cleared
    2002-11-01

    (134 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vital Scientific APTT is an in-vitro diagnostic reagent intended for use in a manual method in a clinical laboratory for the performance of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway.
    Device Description
    The APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic homeostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit brain cephalin with a surface activator.
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    K Number
    K014028
    Device Name
    CARESIDE APTT
    Manufacturer
    CARESIDE HEMOTOLOGY, INC.
    Date Cleared
    2002-02-08

    (64 days)

    Product Code
    GFO, 81G
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For in vitro diagnostic use with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or citrated plasma as an aid in the diagnosis of patients with clotting disorders and to monitor patients receiving heparin anticoagulation therapy.
    Device Description
    CARESIDE APTT cartridges are used with the CARESIDE Analyzer to measure activated partial thromboplastin time from citrated whole blood or plasma as the applied sample. The CARESIDE APTT cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma to a cartridge cuvette to initiate the measurement of an activated partial thromboplastin time. The patented cartridge contains all reagents necessary to measure an activated partial thromboplastin time.
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    K Number
    K014008
    Device Name
    HEMOCHRON JR. CITRATE APTT CUVETTE
    Manufacturer
    ITC, INC.
    Date Cleared
    2002-01-24

    (50 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hemochron Jr. Citrate APTT is a unitized microcoagulation test intended to be used in performing a quantitative one-stage Activated Partial Thromboplastin Time (APTT for monitoring low doses of heparin anticoagulation (up to 1.5 units/ml). The test is performed using a citrated whole blood sample on the Hemochron Jr. microcoagulation instruments. The test is intended for use in point of care settings. For In Vitro Diagnostic Use Only
    Device Description
    The Hemochron Jr.Citrate APTT test is a self-contained disposable test cuvette, pre-filled with dried reagents required to perform an Activated Partial Thromboplastin Time (APTT) using citrated whole blood in the Hemochron Jr. Whole Blood Microcoagulation Analyzers. The preparation consists of kaolin, phospholipid, stabilizers and buffers. These same components are used in the previous formulation of the citrate APTT. The citrate APTT test can be performed on both the Hemochron Jr. II and Hemochron Jr. Signature Series instruments. The test is intended for point of care use. The instrument draws a precise volume of blood into the test channel of the cuvette. The cuvette contains the APTT reagent formulation. An array of LED's detects the motion of the blood sample/reagent mixtures as it moves through the precision channel. The blood is pumped back and forth until a clot begins to form, obstructing the channel and slowing the flow of the blood sample. The instrument detects a clot when the blood movement decreases below a predetermined rate.
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    K Number
    K992711
    Device Name
    SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1999-12-06

    (117 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sigma Diagnostics ALEXIN™ HS is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
    Device Description
    Sigma Diagnostics ALEXIN 14 HS contains purified rabbit brain and soy phospholipids with an ellagic acid activator for the determination of the activated partial thromboplastin time and related coagulation procedures in citrated plasma.
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    K Number
    K992712
    Device Name
    SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
    Manufacturer
    SIGMA DIAGNOSTICS, INC.
    Date Cleared
    1999-12-06

    (117 days)

    Product Code
    GFO
    Regulation Number
    864.7925
    Why did this record match?
    Product Code :

    GFO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sigma Diagnostics ALEXIN™ LS is a device used for primary screening for coagulation Shina Diagnest of evaluation of the effect of therapy on procoagulant disorders, and as able mail.com factor deficiencies of the intrinsic coagulation pathway.
    Device Description
    Sigma Diagnostics ALEXIN™ LS contains purified rabbit brain and sov phospholipids with an ellagic acid activator for the determination of the activated partial thromboplastin time and related coagulation procedures in citrated plasma. This reagent has increased sensitivity to lupus anticoagulants.
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