Cleared Traditional

K093233 - D3 FASTPOINT L-DFA RSV/MVP IDENTIFICATION KIT (FDA 510(k) Clearance)

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

K093233 · Diagnostic Hybrids, Inc. · Microbiology device
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Dec 2009
Decision
51d
Days
Class 2
Risk

K093233 is an FDA 510(k) clearance for the D3 FASTPOINT L-DFA RSV/MVP 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 December 4, 2009 after a review of 51 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 Diagnostic Hybrids, Inc. devices

Submission Details

510(k) Number K093233 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 2009
Decision Date December 04, 2009
Days to Decision 51 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
51d faster than avg
Panel avg: 102d · This submission: 51d
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.