# Control Material, Blood Circulating Epithelial Cancer Cell
> **Product code: 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.

## Market data
- **Cleared 510(k) submissions:** 1
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NRS)
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