# K120986: Stratify JCV Dxselect

- Pathway: 510(k) (Traditional)
- Applicant: Focus Diagnostics, Inc.
- Decided: Aug 16, 2012 after 136 days
- Product code: OYP (Anti-Jcv Antibody Detection Assay)
- Device class: 2
- Regulation: 21 CFR 866.3336
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) STRATIFY JCV Antibody ELISA: named in the summary without a submission number

## Recalls of this device
- Mar 15, 2015 · Class II · Z-1454-2015: Focus Diagnostics is recalling the Stratify JCV Dx Select due to the use of a non-conforming batch in the manufacture of JCV DxSelect EL1950 kit lot #27333. This could lead to a potential for false po

## Indications for use
The Focus Diagnostics' STRATIFY JCV® DxSelectTM assay is intended for the qualitative detection of antibodies to JC virus in human serum or plasma. The assay is intended for use in conjunction *with other clinical data, in multiple sclerosis patients receiving or considering natalizumnab therapy, as an aid in risk stratification for progressive multifocal leukoencephalopatliy development. The assay is for professional use only. The assay is not intended for donor screening. The performance of this assay has not been established for use in other immunocompromised patient populations or patients with different disease conditions of undergoing other, treatments or in. neonates -arid pediatric patient populations.

Source page: https://510kreport.com/device/K120986
Methodology: https://510kreport.com/methodology