Cleared Traditional

K162673 - Aptima Herpes Simplex Viruses 1 & 2 Assay

K162673 is an FDA 510(k) clearance for Aptima Herpes Simplex Viruses 1 & 2 Assay, manufactured by Hologic, Inc.. The device is a Class 2 Microbiology device with product code OQO cleared through the Traditional 510(k) pathway after a 262-day FDA review.

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.

View all Hologic, Inc. devices

FDA 510(k) Submission Details - K162673

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
Combination Product No
PCCP Authorized No
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.

OQO Device Classification - Class 2, Special Controls

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.

Regulatory Peers - OQO Herpes Simplex Virus Nucleic Acid Amplification Assay

Devices cleared under the same product code (OQO) and FDA review panel - the closest regulatory comparables to K162673.
Sentosa SA201 HSV 1/2 Qualitative PCR Test
K172509 · Vela Diagnostics USA, Inc. · Feb 2018
cobas HSV 1 and 2 Test
K150617 · Roche Molecular Systems, Inc. · Jun 2015
AMIPLIVUE HSV 1&2 ASSAY
K140029 · Quidel Corporation · Mar 2014
BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS
K103798 · Becton, Dickinson & CO · Mar 2011