510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K120986Substantially Equivalent

Stratify Jcv Dxselect

DiaSorin Molecular LLC, Cypress CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K120986 is the FDA 510(k) clearance record for STRATIFY JCV DXSELECT, a class II device, cleared for Focus Diagnostics, Inc. on under FDA product code OYP (Anti-Jcv Antibody Detection Assay). FDA's definition for product code OYP reads: "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...". FDA records list 32 510(k) clearances for DiaSorin Molecular LLC, from to . As of , FDA records show one recall naming K120986.

Clearance record

Decision date
Received
(136 days to decision)
Product code
OYP Anti-Jcv Antibody Detection Assay
Regulation
21 CFR 866.3336
Device class
Class II
Review panel
Microbiology
Applicant
Focus Diagnostics, Inc. 11331 Valley View St., Cypress CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYP

Trailing 12 months

FDA records hold no clearances under product code OYP in the trailing twelve months.

FDA records show no clearances under product code OYP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OYP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260