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510(k) K120986

STRATIFY JCV DXSELECT by Focus Diagnostics, Inc. — Product Code OYP

K120986 is an FDA 510(k) premarket notification submitted by Focus Diagnostics, Inc. for the device "STRATIFY JCV DXSELECT". The FDA issued a decision of Substantially Equivalent on August 16, 2012. The device falls under product code OYP (Anti-Jcv Antibody Detection Assay), a Class II device regulated under 21 CFR 866.3336. Focus Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2012
Date Received
April 2, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Jcv Antibody Detection Assay
Device Class
Class II
Regulation Number
866.3336
Review Panel
MI
Submission Type

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.

Other clearances by Focus Diagnostics, Inc.

  • K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (September 21, 2015)
  • K150962 — Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack (August 28, 2015)
  • K143651 — Simplexa Group A Strep Direct, Simplexa Group A Strep Positive Control Pack (March 18, 2015)
  • K142365 — Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack (December 5, 2014)
  • K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (July 1, 2014)
  • DEN130049 — SIMPLEXA HSV 1&2 DIRECT (March 21, 2014)
  • K120413 — SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK (July 13, 2012)
  • K113433 — SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT (April 4, 2012)
  • DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)
  • K102170 — SIMPLEXA FLU A/B & RSV (November 24, 2010)

Other clearances for product code OYP

  • DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)

FDA data resources