DeviceClearance

Product code QSA— Immunology

Parsortix PC1 Device

Classification name
Circulating Tumor Cell (Ctc) Enrichment Device
Device class
Class 2
Regulation
21 CFR 866.6110
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QSA under 21 CFR 866.6110, via openFDA

Market context for product code QSA

FDA has cleared 1 device under product code QSA, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code QSA

Recent clearances under product code QSA

Data sourced from openFDA. This site is unofficial and independent of the FDA.