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510(k) DEN120008

STRATIFY JCV(TM) ANTIBODY by Focus Diagnostics, Inc. — Product Code OYP

DEN120008 is an FDA 510(k) premarket notification submitted by Focus Diagnostics, Inc. for the device "STRATIFY JCV(TM) ANTIBODY". The FDA issued a decision of De Novo Granted on January 20, 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
DENG (De Novo Granted)
Decision Date
January 20, 2012
Date Received
January 6, 2012
Clearance Type
Post-NSE
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)
  • K120986 — STRATIFY JCV DXSELECT (August 16, 2012)
  • 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)
  • K102170 — SIMPLEXA FLU A/B & RSV (November 24, 2010)

Other clearances for product code OYP

  • K120986 — STRATIFY JCV DXSELECT (August 16, 2012)

FDA data resources