System, Immunomagnetic, Circulating Cancer Cell, Enumeration

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

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown