Cleared Traditional

K981120 - ZEUS SCIENTIFIC INC.

K981120 is an FDA 510(k) clearance for ZEUS SCIENTIFIC INC., 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 147-day FDA review.

K981120 · Zeus Scientific, Inc. · Microbiology device
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Aug 1998
Decision
147d
Days
Class 1
Risk

K981120 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on August 21, 1998 after a review of 147 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K981120

510(k) Number K981120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1998
Decision Date August 21, 1998
Days to Decision 147 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
45d slower than avg
Panel avg: 102d · This submission: 147d
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 K981120.
EBV-VCA IGG ELISA TEST SYSTEM
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THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO
K983801 · Zeus Scientific, Inc. · Dec 1998
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
EBV-VCA IGM ELISA TEST STSTEM
K944449 · Zeus Scientific, Inc. · Sep 1995
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K940093 · Gull Laboratories, Inc. · Sep 1995
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K941198 · Gull Laboratories, Inc. · Aug 1995