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510(k) K150962

Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack by Focus Diagnostics — Product Code OQO

K150962 is an FDA 510(k) premarket notification submitted by Focus Diagnostics for the device "Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack". The FDA issued a decision of Substantially Equivalent on August 28, 2015. The device falls under product code OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay), a Class II device regulated under 21 CFR 866.3305. Focus Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2015
Date Received
April 10, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Herpes Simplex Virus Nucleic Acid Amplification Assay
Device Class
Class II
Regulation Number
866.3305
Review Panel
MI
Submission Type

A polymerase chain reaction (pcr)-based qualitative in vitro diagnostic test for the detection and typing of herpes simplex virus (hsv) dna using vaginal swab specimens.

Other clearances by Focus Diagnostics

  • K152408 — Simplexa Flu A/B & RSV Direct and Simplexa Flu A/B & RSV Positive Control Pack (September 21, 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)
  • DEN120008 — STRATIFY JCV(TM) ANTIBODY (January 20, 2012)
  • K102170 — SIMPLEXA FLU A/B & RSV (November 24, 2010)

Other clearances for product code OQO

  • K172509 — Sentosa SA201 HSV 1/2 Qualitative PCR Test (February 1, 2018)
  • K162673 — Aptima Herpes Simplex Viruses 1 & 2 Assay (June 15, 2017)
  • K150617 — cobas HSV 1 and 2 Test (June 1, 2015)
  • K142156 — SEEGENE ANYPLEX II HSV-1/2 ASSAY (February 13, 2015)
  • K142738 — artus HSV-1/2 QS-RGQ MDx Kit (December 19, 2014)
  • K140198 — IMDX HSV-1/2 FOR ABBOTT M2000 (May 13, 2014)
  • K140029 — AMIPLIVUE HSV 1&2 ASSAY (March 26, 2014)
  • K111951 — ISOAMP HSV ASSAY (September 27, 2011)
  • K111527 — MULTICODE-RTX HERPES SIMPLEX VIRUS 1 & 2 KIT (August 3, 2011)
  • K103798 — BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS (March 18, 2011)

FDA data resources