Control Material, Blood Circulating Epithelial Cancer Cell
The Epithelial Cancer Cell Blood Circulating Control Material is a quality control device containing two levels of fixed, fluorescence-stained cells used to verify sample processing and cell analysis performance in circulating tumor cell (CTC) detection systems. It ensures that sample detection and identification systems can reliably detect circulating epithelial tumor cells. This is an FDA Class 2 device regulated under 21 CFR 864.8625 in the Hematology specialty, with product code NRS, and is exempt from premarket notification under submission type 4. It is not an implant and does not provide life-sustaining support.
Basic Information
- Product Code
- NRS
- Device Class
- FDA class 2
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 4
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040898 | CELLSEARCH EPITHELIAL CELL CONTROL KIT | Jun 28, 2004 | Substantially Equivalent | VERIDEX, LLC |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.