Cleared Special

K123838 - PRO HMPV+ ASSAY (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K123838 · Gen-Probe Prodesse, Inc. · Microbiology device
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Jan 2013
Decision
34d
Days
Class 2
Risk

K123838 is an FDA 510(k) clearance for the PRO HMPV+ ASSAY. Classified as Human Metapneumovirus (hmpv) Rna Assay System (product code OEM), Class II - Special Controls.

Submitted by Gen-Probe Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on January 16, 2013 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3980 - the FDA microbiology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Gen-Probe Prodesse, Inc. devices

Submission Details

510(k) Number K123838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2012
Decision Date January 16, 2013
Days to Decision 34 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 102d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OEM Human Metapneumovirus (hmpv) Rna Assay System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition A Qualitative In Vitro Diagnostic Assay Intended To Detect Human Metapneumovirus (hmpv) Rna Extracted From Human Respiratory Specimens Or Viral Cultures. Detection Of Hmpv Rna Aids In The Diagnosis Of Respiratory Hmpv Infection In Conjunction With Other Clinical And Laboratory Testing In Patients Exhibiting Signs And Symptoms Of Upper Respiratory Tract Infections.
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.