Cleared Traditional

K981867 - IS-VZU IGG TEST SYSTEM

K981867 is the FDA 510(k) clearance for IS-VZU IGG TEST SYSTEM by Diamedix Corp.. It is a Class 2 Microbiology device (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

Submission Details

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.

Device Classification

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 10
Devices cleared under the same product code (LFY) and FDA review panel - the closest regulatory comparables to K981867.
DIASORIN LIAISON VZV IGG
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THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
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K941046 · Gull Laboratories, Inc. · Aug 1995
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K923122 · Biomerieux Vitek, Inc. · Oct 1992