Cleared Traditional

Aptima Neisseria gonorrhoeae Assay

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

About This 510(k) Submission

K231329 is an FDA 510(k) clearance for the Aptima Neisseria gonorrhoeae Assay, a Dna-reagents, Neisseria (Class II — Special Controls, product code LSL), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on January 26, 2024, 263 days after receiving the submission on May 8, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3390.

Submission Details

510(k) Number K231329 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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