Cleared Traditional

K091753 - ELVIS HSV ID AND D3 TYPING TEST SYSTEM

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

K091753 · Diagnostic Hybrids, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 22
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