Cleared Special

SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK

K141458 · Focus Diagnostics · Microbiology
Jul 2014
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K141458 is an FDA 510(k) clearance for the SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK, a Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel (Class II — Special Controls, product code PGH), submitted by Focus Diagnostics (Cypress, US). The FDA issued a Cleared decision on July 1, 2014, 29 days after receiving the submission on June 2, 2014. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3307.

Submission Details

510(k) Number K141458 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2014
Decision Date July 01, 2014
Days to Decision 29 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code PGH — Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3307
Definition 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.