Assay, Proliferation, In Vitro, T Lymphocyte
The In Vitro T Lymphocyte Proliferation Assay is a diagnostic device that measures constituents of dividing DNA or other pre-division cellular components to classify the ability of T lymphocytes to divide or proliferate in response to specific or non-specific stimulants. It is used to evaluate immune function in patients with normal or abnormally low T-lymphocyte counts, such as those in a natural or induced immunosuppressed state. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NID and regulation 21 CFR 864.5220 in the Hematology specialty (reviewed by the Immunology panel). The device is eligible for third-party review and is not an implant or life-sustaining device.
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Basic Information
- Product Code
- NID
- Device Class
- FDA class 2
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.