Not Cleared Direct

DEN130049 - SIMPLEXA HSV 1&2 DIRECT (FDA 510(k) Clearance)

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

DEN130049 · Focus Diagnostics · Microbiology device
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Mar 2014
Decision
116d
Days
Class 2
Risk

DEN130049 is an FDA 510(k) submission (not cleared) for the SIMPLEXA HSV 1&2 DIRECT. 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 Not Cleared (DENG) decision on March 21, 2014 after a review of 116 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3307 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

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Submission Details

510(k) Number DEN130049 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 25, 2013
Decision Date March 21, 2014
Days to Decision 116 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 102d · This submission: 116d
Pathway characteristics

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.