Cleared Traditional

K963645 - HERPES GROUP IGG ELISA TEST SYSTEM

K963645 is an FDA 510(k) clearance for HERPES GROUP IGG ELISA TEST SYSTEM, manufactured by Armkel, LLC. The device is a Class 2 Microbiology device with product code LGC cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K963645 · Armkel, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
145d
Days
Class 2
Risk

K963645 is an FDA 510(k) clearance for the HERPES GROUP IGG ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Armkel, LLC (Frederick, US). The FDA issued a Cleared decision on February 4, 1997 after a review of 145 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 Armkel, LLC devices

FDA 510(k) Submission Details - K963645

510(k) Number K963645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1996
Decision Date February 04, 1997
Days to Decision 145 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
43d slower than avg
Panel avg: 102d · This submission: 145d
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 K963645.
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
K983656 · Zeus Scientific, Inc. · Mar 1999
HSV 1+2 IGG ELISA TEST
K983541 · Gull Laboratories, Inc. · Feb 1999
DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM
K981306 · Diamedix Corp. · Sep 1998
SERAQUEST HSV IGG
K963282 · Quest Intl., Inc. · Jan 1997
IMMULITE HERPES I AND II IGG
K950670 · Diagnostic Products Corp. · Jun 1996
PREMIER HSV PLUS
K953839 · Meridian Diagnostics, Inc. · May 1996