Cleared Traditional

STRATIFY JCV DXSELECT

K120986 · Focus Diagnostics, Inc. · Microbiology
Aug 2012
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K120986 is an FDA 510(k) clearance for the STRATIFY JCV DXSELECT, a Anti-jcv Antibody Detection Assay (Class II — Special Controls, product code OYP), submitted by Focus Diagnostics, Inc. (Cypress, US). The FDA issued a Cleared decision on August 16, 2012, 136 days after receiving the submission on April 2, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3336.

Submission Details

510(k) Number K120986 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code OYP — Anti-jcv Antibody Detection Assay
Device Class Class II — 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.