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510(k) DEN130049

SIMPLEXA HSV 1&2 DIRECT by Focus Diagnostics — Product Code PGH

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
March 21, 2014
Date Received
November 25, 2013
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hsv-1 And Hsv-2 Cns Nucleic-Acid Based Panel
Device Class
Class II
Regulation Number
866.3307
Review Panel
MI
Submission Type

Intended for the qualitative detection and differentiation of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of Herpes Simplex Virus (HSV) central nervous system (CNS) infection. This test is an aid in the diagnosis of HSV-1 and HSV-2 CNS infections in conjunction with other clinical and laboratory findings. Negative results do not preclude HSV-1 or HSV-2 infection and should not be used as the sole basis for treatment or other patient management decisions.

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  • 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)
  • 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 PGH

  • K250050 — miDiagnostics HSV-1&2 CSF Test (September 30, 2025)
  • K141458 — SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (July 1, 2014)