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510(k) Data Aggregation
K Number
K221131Device Name
Tasso+
Manufacturer
Tasso, Inc.
Date Cleared
2022-08-12
(116 days)
Product Code
FMK
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Tasso, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples.
Device Description
The Tasso+ device is a sterile, disposable blood lancet. After attachment of a compatible third-party collection tube, the backing is removed from the medical adhesive that is located on the skin side of the device is adhered, in position, to the skin by this adhesive backing.
The device is actuated by pressing the button, causing an energized spring to release and swing the lancet assembly containing a single stainless-steel lancet in an arching motion to create an incision. The lancet contacts the patient momentarily, less than one second, to create a single incision. The mechanism automatically positions the lancet in an inactive position after it has made the incision to prevent sharps injury or re-actuation.
In addition to deploying the lancet, the push of the button generates a slight vacuum to facilitate blood flow under gravity into the blood collection tube. The blood flows from the incision via an open channel in the base and into the compatible tube. The blood flow is one-way, from the skin to the tube, preventing blood re-exposure.
The user is instructed to stop blood collection after a maximum of five minutes of draw time or when the blood reaches the maximum volume fill indicator on the attached tube. The device is then peeled off the skin, and the compatible third-party tube is removed and capped for transport.
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