Not Cleared Post-NSE

DEN120008 - STRATIFY JCV(TM) ANTIBODY

DEN120008 is an FDA 510(k) submission for STRATIFY JCV(TM) ANTIBODY, manufactured by Focus Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code OYP cleared through the Post-NSE 510(k) pathway after a 14-day FDA review.

DEN120008 · Focus Diagnostics, Inc. · Microbiology device
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Jan 2012
Decision
14d
Days
Class 2
Risk

DEN120008 is an FDA 510(k) submission (not cleared) for the STRATIFY JCV(TM) ANTIBODY. Classified as Anti-jcv Antibody Detection Assay (product code OYP), Class II - Special Controls.

Submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Not Cleared (DENG) decision on January 20, 2012 after a review of 14 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3336 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

FDA 510(k) Submission Details - DEN120008

510(k) Number DEN120008 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 06, 2012
Decision Date January 20, 2012
Days to Decision 14 days
Submission Type Post-NSE
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
Pathway characteristics

OYP Device Classification - Class 2, Special Controls

Product Code OYP Anti-jcv Antibody Detection Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3336
Definition The Anti-jcv Antibody Detection Assay Is Intended For The Detection Of Antibodies To The John Cunningham Virus (jcv) In Serum Or Plasma Samples From Multiple Sclerosis (ms) And Crohn's Disease (cd) Patients Receiving Immunomodulatory Therapies.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

DEN120008 · STRATIFY JCV(TM) ANTIBODY
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