Cleared Traditional

K231329 - Aptima Neisseria gonorrhoeae Assay

K231329 is the FDA 510(k) clearance for Aptima Neisseria gonorrhoeae Assay by Hologic, Inc.. It is a Class 2 Microbiology device (product code LSL) cleared through the Traditional 510(k) pathway after a 263-day FDA review.

K231329 · Hologic, Inc. · Microbiology device
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Jan 2024
Decision
263d
Days
Class 2
Risk

K231329 is an FDA 510(k) clearance for the Aptima Neisseria gonorrhoeae Assay. Classified as Dna-reagents, Neisseria (product code LSL), Class II - Special Controls.

Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on January 26, 2024 after a review of 263 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - 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

Submission Details

510(k) Number K231329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2023
Decision Date January 26, 2024
Days to Decision 263 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
161d slower than avg
Panel avg: 102d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LSL Dna-reagents, Neisseria
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
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 - LSL Dna-reagents, Neisseria

All 35
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K231329.
Aptima Combo 2 Assay (Panther System)
K180681 · Hologic, Inc. · Jun 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887 · Roche Molecular Systems, Inc. · Mar 2018
Xpert CT/NG
K173840 · Cepheid · Mar 2018
cobas® CT/NG v2.0 Test
K163184 · Roche Molecular Systems, Inc. · Feb 2017
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY
K140448 · Becton, Dickinson & CO · May 2014
COBAS CT/NG V2.0 TEST
K140887 · Roche Molecular Systems, Inc. · May 2014