Cleared Traditional

K983541 - HSV 1+2 IGG ELISA TEST

K983541 is an FDA 510(k) clearance for HSV 1+2 IGG ELISA TEST, manufactured by Gull Laboratories, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K983541

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.

LGC Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (LGC) and FDA review panel - the closest regulatory comparables to K983541.
POCKIT HSV 2 RAPID TEST
K983886 · Diagnology , Ltd. · Aug 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
SERAQUEST HSV IGG
K963282 · Quest Intl., Inc. · Jan 1997