Cleared Traditional

K983801 - THE APTUS (AUTOMATED) APPLICATION OF TH...

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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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 30
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K983801.
ETI-EA-G ASSAY
K992191 · DiaSorin, Inc. · Jul 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
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120 · Zeus Scientific, Inc. · Aug 1998
EBV-VCA IGM ELISA TEST STSTEM
K944449 · Zeus Scientific, Inc. · Sep 1995