Cleared Traditional

K984181 - THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM

K984181 is an FDA 510(k) clearance for THE APTUS (AUTOMATED) APPLICATION OF TH..., manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code LFY cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K984181 · Zeus Scientific, Inc. · Microbiology device
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Jan 1999
Decision
60d
Days
Class 2
Risk

K984181 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (product code LFY), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 22, 1999 after a review of 60 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K984181

510(k) Number K984181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1998
Decision Date January 22, 1999
Days to Decision 60 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 102d · This submission: 60d
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 K984181.
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
K070317 · Zeus Scientific, Inc. · Jul 2007
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
IS-VZU IGG TEST SYSTEM
K981867 · Diamedix Corp. · Sep 1998
SERAQUEST VZV IGG
K972295 · Quest Intl., Inc. · Nov 1997
VZV IGG ELISA TEST SYSTEM
K961012 · Zeus Scientific, Inc. · Jul 1996