Cleared Traditional

K233352 - Aptima HCV Quant Dx Assay

K233352 is an FDA 510(k) clearance for Aptima HCV Quant Dx Assay, manufactured by Hologic, Inc.. The device is a Class 2 Microbiology device with product code MZP cleared through the Traditional 510(k) pathway after a 299-day FDA review.

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

FDA 510(k) Submission Details - K233352

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.

MZP Device Classification - Class 2, Special Controls

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.