Not Cleared Direct

DEN180040 - Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

DEN180040 is an FDA 510(k) submission for Alethia CMV DNA Amplification Assay, manufactured by Meridian Bioscience, Inc.. The device is a Class 2 Microbiology device with product code QDZ cleared through the Direct 510(k) pathway after a 123-day FDA review.

DEN180040 · Meridian Bioscience, Inc. · Microbiology device
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Nov 2018
Decision
123d
Days
Class 2
Risk

DEN180040 is an FDA 510(k) submission (not cleared) for the Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit. Classified as Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection (product code QDZ), Class II - Special Controls.

Submitted by Meridian Bioscience, Inc. (Cincinnati, US). The FDA issued a Not Cleared (DENG) decision on November 30, 2018 after a review of 123 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3181 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Microbiology review framework.

FDA 510(k) Submission Details - DEN180040

510(k) Number DEN180040 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 30, 2018
Decision Date November 30, 2018
Days to Decision 123 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 102d · This submission: 123d
Pathway characteristics

QDZ Device Classification - Class 2, Special Controls

Product Code QDZ Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3181
Definition The Device Is A Qualitative, In Vitro Diagnostic Test For The Direct Detection Of Cytomegalovirus (cmv) Dna In Saliva From Newborn Babies.
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.

DEN180040 · Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
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