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K Number
K013078
Device Name
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
Manufacturer
HELENA LABORATORIES
Date Cleared
2002-01-10

(118 days)

Product Code
JBP
Regulation Number
864.7140
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ActalykeR Mini™ Activated Clotting Time (ACT) Test System is used to perform the activated clotting time test, a whole blood coagulation assay commonly used to monitor heparin anticoagulation during various medical and surgical procedures. This unit is intended for use in a near-patient or patient-care environment.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the Actalyke Mini device. It does not contain the specific details about acceptance criteria or a study that proves the device meets those criteria. The letter primarily focuses on the device's substantial equivalence to a legally marketed predicate device and regulatory compliance.

Therefore, I cannot extract the requested information from the provided document.

§ 864.7140 Activated whole blood clotting time tests.

(a)
Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.(b)
Classification. Class II (performance standards).