Cleared Traditional

K091753 - ELVIS HSV ID AND D3 TYPING TEST SYSTEM

K091753 is an FDA 510(k) clearance for ELVIS HSV ID AND D3 TYPING TEST SYSTEM, manufactured by Diagnostic Hybrids, Inc.. The device is a Class 2 Microbiology device with product code GQL cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K091753 · Diagnostic Hybrids, Inc. · Microbiology device
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Aug 2009
Decision
73d
Days
Class 2
Risk

K091753 is an FDA 510(k) clearance for the ELVIS HSV ID AND D3 TYPING TEST SYSTEM. Classified as Antisera, Fluorescent, Herpesvirus Hominis 1,2 (product code GQL), Class II - Special Controls.

Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on August 28, 2009 after a review of 73 days - a notably fast clearance 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: 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

FDA 510(k) Submission Details - K091753

510(k) Number K091753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2009
Decision Date August 28, 2009
Days to Decision 73 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
29d faster than avg
Panel avg: 102d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQL Device Classification - Class 2, Special Controls

Product Code GQL Antisera, Fluorescent, 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 - GQL Antisera, Fluorescent, Herpesvirus Hominis 1,2

All 24
Devices cleared under the same product code (GQL) and FDA review panel - the closest regulatory comparables to K091753.
THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH
K984120 · Zeus Scientific, Inc. · May 1999
THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K984135 · Zeus Scientific, Inc. · May 1999
PATHODX HERPES TYPING
K904167 · Diagnostic Products Corp. · Dec 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2
K902661 · Baxter Healthcare Corp · Jul 1990
BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST
K902662 · Baxter Healthcare Corp · Jul 1990
HSV-1 ELISA TEST SYSTEM
K891162 · Zeus Scientific, Inc. · Jun 1989