Cleared Traditional

K983804 - THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR

K983804 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 41-day FDA review.

K983804 · Zeus Scientific, Inc. · Microbiology device
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Dec 1998
Decision
41d
Days
Class 1
Risk

K983804 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZ.... 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 8, 1998 after a review of 41 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 - K983804

510(k) Number K983804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1998
Decision Date December 08, 1998
Days to Decision 41 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
61d faster than avg
Panel avg: 102d · This submission: 41d
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 K983804.
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