Cleared Traditional

Aptima? Chlamydia trachomatis Assay

K230451 · Hologic, Inc. · Microbiology
Nov 2023
Decision
268d
Days
Class 1
Risk

About This 510(k) Submission

K230451 is an FDA 510(k) clearance for the Aptima? Chlamydia trachomatis Assay, a Dna Probe, Nucleic Acid Amplification, Chlamydia (Class I — General Controls, product code MKZ), submitted by Hologic, Inc. (San Diedgo, US). The FDA issued a Cleared decision on November 16, 2023, 268 days after receiving the submission on February 21, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3120.

Submission Details

510(k) Number K230451 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 2023
Decision Date November 16, 2023
Days to Decision 268 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MKZ — Dna Probe, Nucleic Acid Amplification, Chlamydia
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3120

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