Tintelizer TPA

No FDA recalls found in the data synced 5 Oct 2026.

Full name

Tintelizer(R) Tpa

510(k) Number

K934314 ↗

FDA Product Code

GGP

Device Class

Class II

Regulation

21 CFR Part 864.7290

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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• What is the Tintelizer TPA used for?

  The Tintelizer TPA is designed for qualitative and quantitative analysis of coagulation factors, specifically Tissue Plasminogen Activator (TPA) levels. It helps hematologists diagnose and monitor bleeding disorders by providing measurable results to evaluate factor deficiencies in patients.

• How is the Tintelizer TPA supplied and intended for use?

  The Tintelizer TPA is supplied as a test system for laboratory use only and is intended for single-use applications. It is classified under coagulation factor concentrates and adheres to standard in vitro diagnostic (IVD) safety and sterility protocols, ensuring reliable performance in hematology labs.

• Is the Tintelizer TPA sterile and how should it be stored?

  The Tintelizer TPA follows standard IVD sterility protocols, ensuring it is sterile for single-use. Proper storage instructions are provided in the accompanying documentation to maintain stability and accuracy of results. Always refer to the included guidelines for specific storage conditions.

• What regulatory clearance does the Tintelizer TPA have?

  The Tintelizer TPA holds FDA 510(k) clearance under the reference number K934314, classified as a Device Class II (864.7290). This clearance confirms its substantial equivalence to a predicate device and ensures compliance with regulatory standards for coagulation factor testing.

• Can the Tintelizer TPA be reused, and what are its key specifications?

  The Tintelizer TPA is explicitly designed for single-use only, ensuring accuracy and safety. Its specifications include classification under coagulation factor concentrates (Factor VIII and Factor IX) and adherence to FDA 510(k) requirements, with no reuse permitted to maintain diagnostic reliability.