Cleared Traditional

K981867 - IS-VZU IGG TEST SYSTEM

K981867 is an FDA 510(k) clearance for IS-VZU IGG TEST SYSTEM, manufactured by Diamedix Corp.. The device is a Class 2 Microbiology device with product code LFY cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K981867 · Diamedix Corp. · Microbiology device
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Sep 1998
Decision
123d
Days
Class 2
Risk

K981867 is an FDA 510(k) clearance for the IS-VZU IGG TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (product code LFY), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 28, 1998 after a review of 123 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3900 - 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 Diamedix Corp. devices

FDA 510(k) Submission Details - K981867

510(k) Number K981867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1998
Decision Date September 28, 1998
Days to Decision 123 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
21d slower than avg
Panel avg: 102d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFY Device Classification - Class 2, Special Controls

Product Code LFY Enzyme Linked Immunoabsorbent Assay, Varicella-zoster
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3900
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 - LFY Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

All 13
Devices cleared under the same product code (LFY) and FDA review panel - the closest regulatory comparables to K981867.
DIASORIN LIAISON VZV IGG
K061820 · DiaSorin, Inc. · Feb 2007
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
K051484 · Zeus Scientific, Inc. · Dec 2005
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
K984181 · Zeus Scientific, Inc. · Jan 1999
SERAQUEST VZV IGG
K972295 · Quest Intl., Inc. · Nov 1997
VZV IGG ELISA TEST SYSTEM
K961012 · Zeus Scientific, Inc. · Jul 1996
VARICELISA, MODIFICATION
K943843 · Biowhittaker Molecular Applications, Inc. · Mar 1996