Cleared Traditional

K122189 - QUIDEL MOLECULAR RSV + HMPV ASSAY (FDA 510(k) Clearance)

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

K122189 · Quidel Corp. · Microbiology device
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Mar 2013
Decision
227d
Days
Class 2
Risk

K122189 is an FDA 510(k) clearance for the QUIDEL MOLECULAR RSV + HMPV ASSAY. Classified as Human Metapneumovirus (hmpv) Rna Assay System (product code OEM), Class II - Special Controls.

Submitted by Quidel Corp. (San Diego, US). The FDA issued a Cleared decision on March 8, 2013 after a review of 227 days - an extended review 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: 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.

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Submission Details

510(k) Number K122189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2012
Decision Date March 08, 2013
Days to Decision 227 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
125d slower than avg
Panel avg: 102d · This submission: 227d
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.