Cleared Traditional

K984126 - THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR

K984126 is an FDA 510(k) clearance for THE APTUS (AUTOMATED) APPLICATION OF TH..., manufactured by Zeus Scientific, Inc.. The device is a Class 1 Microbiology device with product code MCD cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K984126 · Zeus Scientific, Inc. · Microbiology device
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Jan 1999
Decision
54d
Days
Class 1
Risk

K984126 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN EN.... Classified as Antigen, Ebv, Capsid (product code MCD), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 11, 1999 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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 - K984126

510(k) Number K984126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1998
Decision Date January 11, 1999
Days to Decision 54 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
48d faster than avg
Panel avg: 102d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

MCD Device Classification - Class 1, General Controls

Product Code MCD Antigen, Ebv, Capsid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MCD Antigen, Ebv, Capsid

Devices cleared under the same product code (MCD) and FDA review panel - the closest regulatory comparables to K984126.
EBV-VCA IGG ELISA TEST SYSTEM
K924091 · Zeus Scientific, Inc. · Jan 1993
MODIFIED ORTHO EBV VCA-IGG ELISA
K920412 · Ortho Diagnostic Systems, Inc. · Jun 1992
EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA TEST
K911570 · Ortho Diagnostic Systems, Inc. · Jun 1991
EPSTEIN-BARR VIRUS VCA-IGG ANTIBODY ELISA TEST
K911571 · Ortho Diagnostic Systems, Inc. · Jun 1991
EBV IGG ELISA TEST
K910872 · Gull Laboratories, Inc. · Apr 1991