Control Material, Blood Circulating Epithelial Cancer Cell
NRS · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.8625
Classification
FDA Product Code
NRS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.8625
Review panel
HE
Medical specialty
Hematology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
The Epithelial Cell Control Kit contains two levels of fixed cells that are stained with a fluorescence marker and are used to verify sample processing and cell analysis of circulating tumor cells. This device is used as an assay quality control to ensure that sample detection and identification systems are able to detect circulating epithelial tumor cells.