Cleared Traditional

K142156 - SEEGENE ANYPLEX II HSV-1/2 ASSAY

K142156 is an FDA 510(k) clearance for SEEGENE ANYPLEX II HSV-1/2 ASSAY, manufactured by Seegene. The device is a Class 2 Microbiology device with product code OQO cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K142156 · Seegene · Microbiology device
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Feb 2015
Decision
191d
Days
Class 2
Risk

K142156 is an FDA 510(k) clearance for the SEEGENE ANYPLEX II HSV-1/2 ASSAY. Classified as Herpes Simplex Virus Nucleic Acid Amplification Assay (product code OQO), Class II - Special Controls.

Submitted by Seegene (Beverly, US). The FDA issued a Cleared decision on February 13, 2015 after a review of 191 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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FDA 510(k) Submission Details - K142156

510(k) Number K142156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2014
Decision Date February 13, 2015
Days to Decision 191 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
89d slower than avg
Panel avg: 102d · This submission: 191d
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 Consultant

MDC Associates, LLC
FRAN WHITE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - OQO Herpes Simplex Virus Nucleic Acid Amplification Assay

All 10
Devices cleared under the same product code (OQO) and FDA review panel - the closest regulatory comparables to K142156.
Aptima Herpes Simplex Viruses 1 & 2 Assay
K162673 · Hologic, Inc. · Jun 2017
Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
K150962 · Focus Diagnostics · Aug 2015
cobas HSV 1 and 2 Test
K150617 · Roche Molecular Systems, Inc. · Jun 2015
artus HSV-1/2 QS-RGQ MDx Kit
K142738 · Qiagen · Dec 2014
IMDX HSV-1/2 FOR ABBOTT M2000
K140198 · Intelligent Medical Devices, Inc. · May 2014
AMIPLIVUE HSV 1&2 ASSAY
K140029 · Quidel Corporation · Mar 2014