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510(k) Data Aggregation
K Number
K990398Device Name
PLATELETWORKS
Manufacturer
Date Cleared
1999-12-01
(295 days)
Product Code
Regulation Number
864.5700Why did this record match?
Applicant Name (Manufacturer) :
ARRAY MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation in fresh whole blood samples taken during cardiac interventional procedures as measured by a change in platelet count due to activation of functional platelets. It may be used at the point-of-care on the Ichor hematology analyzer as a screening tool for the detection of trends suggestive of platelet dysfunction. Any abnormal baseline or otherwise suspicious result would require repeating the Plateletworks test procedure and/or further additional investigation with more definitive test methods, including conventional platelet aggregometry.
Device Description
Plateletworks is a unitized screening assay for determining platelet aggregation in a whole blood sample using the Ichor hematology analyzer. The Plateletworks methodology is an adaptation of platelet aggregometry that is extremely simple, and quick to perform (results are available in about five minutes). This method involves using the Ichor hematology analyzer (based on electronic impedance principles) to measure total platelet count in a whole blood sample and then to redetermine the number of platelets in a second sample that has been exposed to a known platelet agonist. The agonist will stimulate those platelets which are functional to aggregate into clumps, and they will not be counted as platelets in the second sample. The difference in platelet counts between samples one and two provides a direct measurement of platelet aggregation and is reported as percent aggregation as per the following equation: Baseline Platelet Count - Agonist Platelet Count x 100 = % Aggregation Baseline Platelet Count
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K Number
K983649Device Name
MAX-ACT
Manufacturer
Date Cleared
1998-12-11
(56 days)
Product Code
Regulation Number
864.7140Why did this record match?
Applicant Name (Manufacturer) :
ARRAY MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MAX-ACT Activated Clotting Time test tubes are intended for use in the measurement of the activated clotting time test (ACT) on Actalyke Models A1, A1P, A2, A2P, and Hemochron® Models 400, 401, 800, 801 and 8000.
Device Description
The MAX-ACT Activated Clotting Time test tubes utilize a "cocktail" of particulate activators (including celite, kaolin, and glass particles) and is intended for use in the measurement of the activated clotting time test (ACT) on Actalyke Models A1, A1P, A2, A2P, and Hemochron® Models 400, 401, 800, 801 and 8000.
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K Number
K964609Device Name
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
Manufacturer
Date Cleared
1997-03-06
(108 days)
Product Code
Regulation Number
864.7140Why did this record match?
Applicant Name (Manufacturer) :
ARRAY MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Actalyke Activated Clotting Time System and Test Tubes are intended for use in the measurement of the activated clotting time test (ACT). Current markets using the ACT include: bypass surgery, vascular surgery, transplant surgery, renal dialysis, ECMO, cardiac catheterization and Percutaneous Transluminal Coronary Angioplasty (PTCA), Critical Care, and other medical therapies requiring heparin anticoagulation.
Device Description
The Actalyke System is a portable, battery operated device designed to perform a range of whole blood coagulation tests at the patient's bedside using Activated Clotting Time (ACT) measurement techniques. Each test well of the Actalyke Instrument incorporates a highly sensitive clot detection mechanism. Operationally, the detection mechanism comprises a magnet located inside a test tube and two solid state magnetic detectors positioned within the test well - one situated at 0° and another situated at 90° with respect to the test tube. When a test tube is inserted into the test well, the detector at 0° senses the presence of the magnet as the tube slowly rotates. As clotting forms, the fibrin strands cause the magnet to rotate within the tube such that its presence is sensed by the detector at 90° (indicating the occurrence of clotting and triggering end-point detection). This two-point detection sensing system is an improvement in ACT detection methods and minimizes the possibility of a missed end-point. Each Actalyke test tube has a barcode label affixed to it, which is read by the Actalyke instrument to determine the test tube type (i.e., celite, kaolin, or glass bead), If the result is printed (optional), the normal range for the identified test tube type will be printed. The lot number and expiration date of each tube are also identified on the barcode label.
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