21 CFR 862.1164 — Setmelanotide Eligibility Gene Variant Detection System

Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1164

Identification

The POMC/PCSK1/LEPR CDx Panel is a next generation sequencing (NGS)-based in vitro diagnostic test that analyzes genomic DNA isolated from blood or saliva. The test detects germline nucleotide substitutions, short insertions and deletions, and copy number variants (CNVs) within the POMC, PCSK1, and LEPR genes. It is a companion diagnostic device intended to select adult and pediatric patients 6 years of age and older who have obesity and certain variants in these genes for treatment with IMCIVREE (setmelanotide).

Classification Rationale

Class II (special controls). The device is subject to the special controls identified in the De Novo classification order to mitigate risks of incorrect performance or interpretation of genetic data leading to false positive or false negative results.

Product Codes