Cleared Traditional

PRO HMPV+ ASSAY (K082688) - FDA 510(k) Clearance

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

K082688 · Prodesse, Inc. · Microbiology device
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Nov 2008
Decision
53d
Days
Class 2
Risk

K082688 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 Prodesse, Inc. (Waukesha, US). The FDA issued a Cleared decision on November 7, 2008 after a review of 53 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prodesse, Inc. devices

Submission Details

510(k) Number K082688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2008
Decision Date November 07, 2008
Days to Decision 53 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 102d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.