21 CFR 864.7298 — Non-Factor Replacement Product Test System

Hematology (HE) · Part 864 Subpart H—Hematology Kits and Packages · § 864.7298

Identification

The ConcizuTrace ELISA is a manual, quantitative enzyme-linked immunosorbent assay (ELISA) intended for the measurement of concizumab concentration in human 3.2% citrated plasma samples from Hemophilia A and B patients after 4 weeks from the initiation of treatment with concizumab. The measurement is used for dose adjustment decisions in accordance with the drug label. The assay is performed by qualified healthcare professionals using a qualified microplate reader.

Classification Rationale

Class II (special controls). The device is classified as a non-factor replacement product test system under 21 CFR 864.7298. The FDA determined that general controls alone are insufficient to mitigate the risks of false test results, failure of the system to perform as intended, or failure to correctly interpret results, which could lead to inappropriate or delayed treatment decisions. Special controls, in addition to general controls, provide reasonable assurance of safety and effectiveness.

Product Codes