21 CFR 864.7297 — Adamts13 Activity Test System

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7297

Identification

The Technozym ADAMTS13 Activity assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative determination of ADAMTS13 activity in platelet-poor human citrated plasma. It is used in conjunction with other clinical and laboratory findings as an aid in the diagnosis of thrombotic thrombocytopenic purpura (TTP) in adult and pediatric patients being evaluated for thrombotic microangiopathy (TMA).

Classification Rationale

Class II with special controls. The device is classified as Class II because general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, but the risks can be mitigated by special controls including design verification, validation, and specific labeling requirements.

Product Codes