510(k) Report

De Novo · Granted

Granted

Stratify JCV (TM) Antibody

DEN120008De NovoGranted Jan 20, 201214-day reviewClass II21 CFR 866.3336

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Focus Diagnostics, Inc. · OYP Anti-Jcv Antibody Detection Assay

Granted on Jan 20, 2012 as a new device type through De Novo after a 14-day review.

Decided
Jan 20, 2012
Review
14 days
Class
Class II
Product code
OYP
Recalls
None

De Novo grants create a new device type without a predicate, so this family tree starts here.

FIG. 1 — Lineage of DEN120008Source: FDA De Novo database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA De Novo database (decision fields), 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
Get a 510(k) Report

Does it have a predicate?

De Novo decisions do not claim a predicate device.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All OYP devices

OYP 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

2012: 2
2007high 2 (2012) · low 0 (2007)2026

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

2015: 12022: 1
2007high 1 (2015) · low 0 (2007)2025

MAUDE reports naming product code OYP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20122—00
20130—00
20140—00
20150—01
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—

More from Focus Diagnostics, Inc.

14 FDA decisions under this applicant name. See the company

  • K152408Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control PackFocus Diagnostics, Inc. · 20151 recall
  • K143651Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control PackFocus Diagnostics, Inc. · 20151 Class I recall
  • K120986Stratify JCV DxselectFocus Diagnostics, Inc. · 20121 recall
  • K120413Simplexa Flu a/B & RSV Direct, Simplexa Flu a/B & RSV Positive Control PackFocus Diagnostics, Inc. · 20122 recalls
  • K113433Simplexa C. Difficile Universal DirectFocus Diagnostics, Inc. · 2012

Recent decisions in OYP

The OYP category page

  • K120986Stratify JCV DxselectFocus Diagnostics, Inc. · 20121 recall

https://510kreport.com/device/DEN120008 · printed Nov 4, 2026

Cite this page

510(k) Report. “DEN120008: Stratify JCV (TM) Antibody.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN120008

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026