Comparison of SEPAX & SEPAX 2
Comparison of SEPAX & SEPAX 2
Comparison of SEPAX & SEPAX 2
Product:
Trade name: Sepax Cell Separation System and single use kits
Common name: Sepax 2 system
Classification name: Cord blood processing system and storage container
Classification: class II - special controls
Predicate device:
Sepax Cell Separation System and single use kits cleared as bk060036
Device Description:
The Sepax 2 is the modified version of the Sepax main processing unit. The Sepax 2 is
an evolution of the legally marketed (unmodified) Sepax. There is no change in its
intended use and in its fundamental scientific technology.
Intended Use:
The Sepax system is a cord blood cell processing system intended for laboratory use in
exclusive combination with a compatible single-use separation kit supplied by Biosafe.
The cord blood to be processed has been previously collected and transported to the
laboratory by other means.
The Sepax system allows the fast, automated and reproducible separation of cord
blood. The Sepax system is not intended for use in transfusion applications at bedside,
where blood circulates directly between a patient and the Sepax unit.
Sepax Sepax 2
Clearance Cleared under 510(k) bk060036 Notification of modification
under the present 510(k)
General
Intended use / See Intended use Statement Same
Indication for use
Fundamental The machine in conjunction with Same
scientific a sterile single use kit is used for
technology cord blood cell separation.
Conclusion:
It is the conclusion of Biosafe that the Sepax 2 system is substantially equivalent to
and as safe and effective as the predicate device.
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