# System, Immunomagnetic, Circulating Cancer Cell, Enumeration
> **Product code: NQI** · Class II — Moderate Risk (510(k) clearance required) · Immunology · 21 CFR 866.6020
## Classification
- **FDA Product Code:** NQI
- **Device class:** Class II — Moderate Risk (510(k) clearance required)
- **Regulation:** 21 CFR 866.6020
- **Review panel:** PA
- **Medical specialty:** Immunology
- **Submission type:** 1
- **GMP exempt:** N
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## Definition

In vitro diagnostic device to aid in the enumeration of immunomagnetically selected and fluorescently identified circulating tumor cells of epithelial origin in whole blood for prediction of cancer progression and survival.

## Market data
- **Cleared 510(k) submissions:** 13
- **Registered establishments:** 3
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NQI)
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