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K Number
K972796
Device Name
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
Manufacturer
SIGMA DIAGNOSTICS, INC.
Date Cleared
1997-10-10

(74 days)

Product Code
GJS
Regulation Number
864.7750
Type
Traditional
Panel
HE
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Sigma Diagnostics ThromboMAX™ with Calcium is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).

Device Description

Sigma ThromboMAX™ with Calcium is a lyophilized preparation of thromboplastin derived from rabbit brain with buffers, stabilizers, and calcium ions. It is intended for use in the one-stage Prothrombin Time (PT) test and in PT based assays.

AI/ML Overview

§ 864.7750 Prothrombin time test.

(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).