Cleared Traditional

K983801 - THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO

K983801 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 LSE cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K983801 · Zeus Scientific, Inc. · Microbiology device
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Dec 1998
Decision
43d
Days
Class 1
Risk

K983801 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN E.... Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on December 10, 1998 after a review of 43 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 - K983801

510(k) Number K983801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1998
Decision Date December 10, 1998
Days to Decision 43 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
59d faster than avg
Panel avg: 102d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

LSE Device Classification - Class 1, General Controls

Product Code LSE Epstein-barr Virus, Other
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 - LSE Epstein-barr Virus, Other

All 51
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K983801.
BIOTEST ANTI-EBV RECOMBINANT, EA IGM
K983842 · Biotest Diagnostics Corp. · Jun 1999
COPALIS MULTIPLEX EBV ANTIBODY ASSAY
K991660 · DiaSorin, Inc. · Jun 1999
EBV-VCA IGG ELISA TEST SYSTEM
K981812 · Diamedix Corp. · Mar 1999
THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR
K983804 · Zeus Scientific, Inc. · Dec 1998
EBNA-1 IGM ELISA TEST SYSTEM
K982348 · Columbia Bioscience, Inc. · Nov 1998
EA-D IGM ELISA TEST SYSTEM
K982350 · Columbia Bioscience, Inc. · Nov 1998