Cleared Traditional

K230451 - Aptima® Chlamydia trachomatis Assay (FDA 510(k) Clearance)

Class I Microbiology device.

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

K230451 is an FDA 510(k) clearance for the Aptima® Chlamydia trachomatis Assay. Classified as Dna Probe, Nucleic Acid Amplification, Chlamydia (product code MKZ), Class I - General Controls.

Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on November 16, 2023 after a review of 268 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3120 - 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 K230451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 102d · This submission: 268d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3120
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.