OYP · Anti-Jcv Antibody Detection Assay
Microbiology · 21 CFR 866.3336 · Class 2
Overview
| Product Code | OYP |
|---|---|
| Device Name | Anti-Jcv Antibody Detection Assay |
| Regulation | 21 CFR 866.3336 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
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).
Special Controls
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.
*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).
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120986 | STRATIFY JCV DXSELECT | Focus Diagnostics, Inc. | Aug 16, 2012 | SESE |
| DEN120008 | STRATIFY JCV(TM) ANTIBODY | Focus Diagnostics, Inc. | Jan 20, 2012 | DENG |
Top Applicants
- Focus Diagnostics, Inc. — 2 clearances
