Cleared Traditional

K233352 - Aptima HCV Quant Dx Assay (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233352 · Hologic, Inc. · Microbiology device
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Jul 2024
Decision
299d
Days
Class 2
Risk

K233352 is an FDA 510(k) clearance for the Aptima HCV Quant Dx Assay. Classified as Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus (product code MZP), Class II - Special Controls.

Submitted by Hologic, Inc. (San Diego, US). The FDA issued a Cleared decision on July 24, 2024 after a review of 299 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3170 - 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 K233352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date July 24, 2024
Days to Decision 299 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
197d slower than avg
Panel avg: 102d · This submission: 299d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MZP Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3170
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.