Cleared Traditional

K142738 - artus HSV-1/2 QS-RGQ MDx Kit

K142738 is an FDA 510(k) clearance for artus HSV-1/2 QS-RGQ MDx Kit, manufactured by Qiagen. The device is a Class 2 Microbiology device with product code OQO cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K142738 · Qiagen · Microbiology device
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Optimized for regulatory review, auditing and printing
Dec 2014
Decision
87d
Days
Class 2
Risk

K142738 is an FDA 510(k) clearance for the artus HSV-1/2 QS-RGQ MDx Kit. Classified as Herpes Simplex Virus Nucleic Acid Amplification Assay (product code OQO), Class II - Special Controls.

Submitted by Qiagen (Germantown, US). The FDA issued a Cleared decision on December 19, 2014 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Qiagen devices

FDA 510(k) Submission Details - K142738

510(k) Number K142738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2014
Decision Date December 19, 2014
Days to Decision 87 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
15d faster than avg
Panel avg: 102d · This submission: 87d
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

Qiagen Gaitherburg
Kimberly Mapp

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 K142738.
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