Automated Multicolor Fluorescent Imaging Cytometric Analysis System
PMG · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5220
Classification
FDA Product Code
PMG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.5220
Review panel
HE
Medical specialty
Hematology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
An automated multicolor fluorescent imaging cytometer and absorbance spectrometer which utilizes specific single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters (e.g., hemoglobin) using spectrophotometric absorbance measurement and fluorescence measurements.