Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment
QFS · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.3215
Classification
FDA Product Code
QFS
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.3215
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
An elevated Monocyte Distribution Width (MDW) value, together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis following hospital admission. MDW should not be used as the sole basis to determine the absence of sepsis.