Cleared Special

K141458 - SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K141458 · Focus Diagnostics · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
29d
Days
Class 2
Risk

K141458 is an FDA 510(k) clearance for the SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK. Classified as Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel (product code PGH), Class II - Special Controls.

Submitted by Focus Diagnostics (Cypress, US). The FDA issued a Cleared decision on July 1, 2014 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3307 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K141458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code PGH Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.