Cleared Traditional

K162673 - Aptima Herpes Simplex Viruses 1 & 2 Assay (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K162673 · Hologic, Inc. · Microbiology device
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Jun 2017
Decision
262d
Days
Class 2
Risk

K162673 is an FDA 510(k) clearance for the Aptima Herpes Simplex Viruses 1 & 2 Assay. Classified as Herpes Simplex Virus Nucleic Acid Amplification Assay (product code OQO), Class II - Special Controls.

Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on June 15, 2017 after a review of 262 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K162673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2016
Decision Date June 15, 2017
Days to Decision 262 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
160d slower than avg
Panel avg: 102d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
Definition 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.
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.