Cleared Traditional

K061101 - D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT (FDA 510(k) Clearance)

Class I Microbiology device.

K061101 · Diagnostic Hybrids, Inc. · Microbiology device
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Nov 2006
Decision
214d
Days
Class 1
Risk

K061101 is an FDA 510(k) clearance for the D3 ULTRA DFA RESPIRATORY VIRUS SCREENING & ID KIT. Classified as Antisera, Cf, Influenza Virus A, B, C (product code GNW), Class I - General Controls.

Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on November 20, 2006 after a review of 214 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3330 - 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 K061101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2006
Decision Date November 20, 2006
Days to Decision 214 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
112d slower than avg
Panel avg: 102d · This submission: 214d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GNW Antisera, Cf, Influenza Virus A, B, C
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3330
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.