QSA

Circulating Tumor Cell (Ctc) Enrichment Device

Product code

QSA

Device name

Circulating Tumor Cell (Ctc) Enrichment Device

Device class

Class 2

21 CFR

21 CFR 866.6110

Medical specialty

Immunology

Marketing pathway

510(K)

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

A circulating tumor cell enrichment device is an in vitro diagnostic device used to enrich circulating tumor cells from the peripheral blood of patients diagnosed with cancer for subsequent in vitro diagnostic testing.

Definition text from the FDA device classification database (U.S. federal government work, public domain).