Cleared Traditional

K960578 - ELVIS HSV GOLD

K960578 is an FDA 510(k) clearance for ELVIS HSV GOLD, 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 206-day FDA review.

K960578 · Diagnostic Hybrids, Inc. · Microbiology device
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Sep 1996
Decision
206d
Days
Class 2
Risk

K960578 is an FDA 510(k) clearance for the ELVIS HSV GOLD. 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 5, 1996 after a review of 206 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 - K960578

510(k) Number K960578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1996
Decision Date September 05, 1996
Days to Decision 206 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
104d slower than avg
Panel avg: 102d · This submission: 206d
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 K960578.
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
K941924 · Diagnostic Hybrids, Inc. · May 1995
HSV IN SITU DNA PROBE HYBRIDIZATION TEST KIT
K911345 · Diagnostic Hybrids, Inc. · Jun 1991
MODIFIED CELL-MATICS HERPES SIMPLEX VIRUS DETECT.
K884761 · Difco Laboratories, Inc. · Dec 1988