Cleared Traditional

K941924 - ELVIS HSV

K941924 is the FDA 510(k) clearance for ELVIS HSV by Diagnostic Hybrids, Inc.. It is a Class 2 Microbiology device (product code GQN) cleared through the Traditional 510(k) pathway after a 376-day FDA review.

K941924 · Diagnostic Hybrids, Inc. · Microbiology device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
376d
Days
Class 2
Risk

K941924 is an FDA 510(k) clearance for the ELVIS HSV. 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 May 1, 1995 after a review of 376 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K941924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1994
Decision Date May 01, 1995
Days to Decision 376 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
274d slower than avg
Panel avg: 102d · This submission: 376d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 14
Devices cleared under the same product code (GQN) and FDA review panel - the closest regulatory comparables to K941924.
DIAGNOSTIC HYBRIDS' D3 DFA HERPES SIMPLEX VIRUS IDENTIFICATION KIT, MODEL 01-080000
K063798 · Diagnostic Hybrids, Inc. · Sep 2007
ELVIS HSV ID/TYPING TEST SYSTEM
K971662 · Diagnostic Hybrids, Inc. · Nov 1997
ELVIS HSV GOLD
K960578 · Diagnostic Hybrids, Inc. · Sep 1996
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
HYBRIWICK SYSTEM: HERPES DNA PROBE TEST KIT
K873529 · Diagnostic Hybrids, Inc. · Aug 1988