Not Cleared Direct

DEN180047 - Aptima Mycoplasma genitalium Assay

DEN180047 is an FDA 510(k) submission for Aptima Mycoplasma genitalium Assay, manufactured by Hologic, Inc.. The device is a Class 2 Microbiology device with product code QEP cleared through the Direct 510(k) pathway after a 145-day FDA review.

DEN180047 · Hologic, Inc. · Microbiology device
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Jan 2019
Decision
145d
Days
Class 2
Risk

DEN180047 is an FDA 510(k) submission (not cleared) for the Aptima Mycoplasma genitalium Assay. Classified as Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections (product code QEP), Class II - Special Controls.

Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Not Cleared (DENG) decision on January 23, 2019 after a review of 145 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3393 - 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.

FDA 510(k) Submission Details - DEN180047

510(k) Number DEN180047 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 31, 2018
Decision Date January 23, 2019
Days to Decision 145 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 102d · This submission: 145d
Pathway characteristics

QEP Device Classification - Class 2, Special Controls

Product Code QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3393
Definition A Device To Detect Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Nucleic Acids From Non-viral Microorganism(s) In Clinical Specimens Collected From Patients Suspected Of Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Non-viral Sexually Transmitted Infections In Conjunction With Other Clinical And Laboratory Data.
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 - QEP Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections

All 23
Devices cleared under the same product code (QEP) and FDA review panel - the closest regulatory comparables to DEN180047.
Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit
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K190433 · Roche Molecular Systems, Inc. · May 2019
DEN180047 · Aptima Mycoplasma genitalium Assay
Download PDF Hologic, Inc.