510(k) · Cleared
Recalled · Class II · 2015Stratify JCV Dxselect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Focus Diagnostics, Inc. · OYP Anti-Jcv Antibody Detection Assay
Cleared on Aug 16, 2012 after a 136-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Aug 16, 2012
- Review
- 136 days
- Class
- Class II
- Product code
- OYP
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OYP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | STRATIFY JCV Antibody ELISA Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 15, 2015 | Class II | Z-1454-2015 | Nonconforming Material/Component | 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 positive JCV results. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All OYP devicesOYP Anti-Jcv Antibody Detection Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · OYP
2in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · OYP
Too few OYP 510(k)s in any year since 2007 to give a median.
Recalls per year · OYP
No recall names OYP since 2007.
Adverse event reports per year · OYP
1in 2022
MAUDE reports naming product code OYP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (103 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120986 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120986: Stratify JCV Dxselect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120986
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026