510(k) K150962

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

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

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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)

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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)