21 CFR 866.3336 — Anti-Jcv Antibody Detection Assay
Microbiology (MI) · Part 866 Subpart D—Serological Reagents · § 866.3336
Identification
John Cunningham Virus serological reagents are devices that consist of antigens and antisera used in serological assays to identify antibodies to John Cunningham Virus in serum and plasma. The identification aids in the risk stratification for the development of progressive multifocal leukoencephalopathy in multiple sclerosis and Crohn's disease patients undergoing natalizumab therapy. These devices are for adjunctive use, in the context of other clinical risk factors for the development of progressive multifocal leukoencephalopathy.
Classification Rationale
Class II (special controls). The special control for this device is the FDA guideline document entitled “Class II Special Controls Guideline: John Cunningham Virus Serological Reagents.” For availability of the guideline document, see § 866.1(e).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| OYP | Anti-Jcv Antibody Detection Assay | 2 | 2 |
Special Controls
OYP — Anti-Jcv Antibody Detection Assay
The device is classified as Class II under regulation 21 CFR 866.3336 with special controls. The special control guidance document "Class II Special Controls Guidance Document: John Cunningham Virus Serological Reagents," will be available shortly.
De Novo Order DEN120008
OYP — Anti-Jcv Antibody Detection Assay
*Classification.* Class II (special controls). The special control for this device is the FDA guideline document entitled “Class II Special Controls Guideline: John Cunningham Virus Serological Reagents.” For availability of the guideline document, see § 866.1(e).
eCFR
OYP — Anti-Jcv Antibody Detection Assay
The special control for this device is the FDA guideline document entitled “Class II Special Controls Guideline: John Cunningham Virus Serological Reagents.” For availability of the guideline document, see § 866.1(e).
Ecfr Llm
