Cleared Traditional

K120986 - STRATIFY JCV DXSELECT (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120986 · Focus Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
136d
Days
Class 2
Risk

K120986 is an FDA 510(k) clearance for the STRATIFY JCV DXSELECT. 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 Cleared decision on August 16, 2012 after a review of 136 days - within the typical 510(k) review window.

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 establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Focus Diagnostics, Inc. devices

Submission Details

510(k) Number K120986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2012
Decision Date August 16, 2012
Days to Decision 136 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d slower than avg
Panel avg: 102d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.