Cleared Traditional

K963282 - SERAQUEST HSV IGG

K963282 is an FDA 510(k) clearance for SERAQUEST HSV IGG, manufactured by Quest Intl., Inc.. The device is a Class 2 Microbiology device with product code LGC cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K963282 · Quest Intl., Inc. · Microbiology device
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Jan 1997
Decision
154d
Days
Class 2
Risk

K963282 is an FDA 510(k) clearance for the SERAQUEST HSV IGG. Classified as Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific (product code LGC), Class II - Special Controls.

Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 154 days - an extended review 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: 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 Quest Intl., Inc. devices

FDA 510(k) Submission Details - K963282

510(k) Number K963282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1996
Decision Date January 22, 1997
Days to Decision 154 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
52d slower than avg
Panel avg: 102d · This submission: 154d
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 K963282.
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
HERPES GROUP IGG ELISA TEST SYSTEM
K963645 · Armkel, LLC · Feb 1997
IMMULITE HERPES I AND II IGG
K950670 · Diagnostic Products Corp. · Jun 1996
PREMIER HSV PLUS
K953839 · Meridian Diagnostics, Inc. · May 1996
ORTHO HSV ANTIGEN ELISA TEST, MODIFICATION
K925208 · Ortho Diagnostic Systems, Inc. · Dec 1992