NID · Class II — Moderate Risk (510(k) clearance required) · Hematology · 21 CFR 864.5220
Classification
FDA Product Code
NID
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 864.5220
Review panel
IM
Medical specialty
Hematology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or non-specific added stimulants. The T lymphocytes may be normal in number or abnormally low in number due to a natural or induced immunosuppressed state in the patient.