Cleared Traditional

K231329 - Aptima Neisseria gonorrhoeae Assay

K231329 is an FDA 510(k) clearance for Aptima Neisseria gonorrhoeae Assay, manufactured by Hologic, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K231329

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.

LSL Device Classification - Class 2, Special Controls

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 41
Devices cleared under the same product code (LSL) and FDA review panel - the closest regulatory comparables to K231329.
Aptima Combo 2 Assay (Panther System)
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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
ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG
K140354 · Abbott Molecular, Inc. · May 2014