Cleared Traditional

K984126 - THE APTUS (AUTOMATED) APPLICATION OF TH...

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