Cleared Traditional

K983541 - HSV 1+2 IGG ELISA TEST

K983541 is the FDA 510(k) clearance for HSV 1+2 IGG ELISA TEST by Gull Laboratories, Inc.. It is a Class 2 Microbiology device (product code LGC) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K983541 · Gull Laboratories, Inc. · Microbiology device
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Feb 1999
Decision
140d
Days
Class 2
Risk

K983541 is an FDA 510(k) clearance for the HSV 1+2 IGG ELISA TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 26, 1999 after a review of 140 days - within the typical 510(k) review window.

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 Gull Laboratories, Inc. devices

Submission Details

510(k) Number K983541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1998
Decision Date February 26, 1999
Days to Decision 140 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
38d slower than avg
Panel avg: 102d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
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 - LGC Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific

All 27
Devices cleared under the same product code (LGC) and FDA review panel - the closest regulatory comparables to K983541.
THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K992166 · Zeus Scientific, Inc. · Sep 1999
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
K984346 · Meridian Diagnostics, Inc. · Jun 1999
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
K983656 · Zeus Scientific, Inc. · Mar 1999
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
K981306 · Diamedix Corp. · Sep 1998
HERPES GROUP IGG ELISA TEST SYSTEM
K963645 · Armkel, LLC · Feb 1997
IMMULITE HERPES I AND II IGG
K950670 · Diagnostic Products Corp. · Jun 1996