Cleared Traditional

K091171 - D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT (FDA 510(k) Clearance)

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

K091171 · Diagnostic Hybrids, Inc. · Microbiology device
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Sep 2009
Decision
142d
Days
Class 2
Risk

K091171 is an FDA 510(k) clearance for the D3 ULTRA DUET DFA RESPIRATORY VIRUS IDENTIFICATION KIT. Classified as Antisera, Fluorescent, Human Metapneumovirus (product code OMG), Class II - Special Controls.

Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on September 11, 2009 after a review of 142 days - within the typical 510(k) review window.

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.

View all Diagnostic Hybrids, Inc. devices

Submission Details

510(k) Number K091171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2009
Decision Date September 11, 2009
Days to Decision 142 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
40d slower than avg
Panel avg: 102d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OMG Antisera, Fluorescent, Human Metapneumovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3980
Definition It Is Intended For The Qualitative Detection And Identification Of Human Metapneumovirus (hmpv) In Direct Respiratory Specimens Or Cell Culture. The Assay Detects Hmpv Antigens By Immunofluorescence Using Antibodies, From Patients With Signs And Symptoms Of Acute Respiratory Infection. This Assay Detects But Is Not Intended To Differentiate The Four Recognized Genetic Sub-lineages Of Hmpv.
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.