21 CFR 866.6110 — Circulating Tumor Cell (Ctc) Enrichment Device

Immunology (IM) · De Novo Classifications · § 866.6110

Identification

The Parsortix® PC1 system is an in vitro diagnostic device intended to enrich circulating tumor cells (CTCs) from peripheral blood collected in K2EDTA tubes from patients diagnosed with metastatic breast cancer. The system employs a microfluidic chamber (a Parsortix cell separation cassette) to capture cells of a certain size and deformability from the population of cells present in blood. The cells retained in the cassette are harvested by the Parsortix PC1 system for use in subsequent downstream assays.

Classification Rationale

Class II (special controls). The device is classified under 21 CFR 866.6110, subject to special controls to mitigate risks such as failure to identify CTCs, incorrect evaluation of CTCs, and improper device operation.

Product Codes