Cleared Traditional

K063798 - DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000

K063798 is an FDA 510(k) clearance for DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPL..., manufactured by Diagnostic Hybrids, Inc.. The device is a Class 2 Microbiology device with product code GQN cleared through the Traditional 510(k) pathway after a 273-day FDA review.

K063798 · Diagnostic Hybrids, Inc. · Microbiology device
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Sep 2007
Decision
273d
Days
Class 2
Risk

K063798 is an FDA 510(k) clearance for the DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-.... Classified as Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2 (product code GQN), Class II - Special Controls.

Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on September 21, 2007 after a review of 273 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3305 - 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

FDA 510(k) Submission Details - K063798

510(k) Number K063798 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2006
Decision Date September 21, 2007
Days to Decision 273 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 102d · This submission: 273d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQN Device Classification - Class 2, Special Controls

Product Code GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3305
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.

Regulatory Peers - GQN Antigen, Cf (including Cf Control), Herpesvirus Hominis 1,2

All 22
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K063798.
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION AND TYPING KIT, MODEL 01-090000
K070265 · Diagnostic Hybrids, Inc. · Oct 2007
LIGHT DIAGNOSTICS SIMULFLUOR HSV 1/2 IMMUNOFLUORECENCE ASSAY
K991880 · Light Diagnostics · Nov 1999
ELVIS HSV ID/TYPING TEST SYSTEM
K971662 · Diagnostic Hybrids, Inc. · Nov 1997
HSV-1 ANTIGEN CONTROL SLIDES
K964874 · Viral Antigens, Inc. · Jul 1997
HSV-2 ANTIGEN CONTROL SLIDES
K971101 · Viral Antigens, Inc. · Jul 1997
ELVIS HSV GOLD
K960578 · Diagnostic Hybrids, Inc. · Sep 1996