Cleared Traditional

K833014 - EBV-VCA-IGM IFA TEST SYSTEM

K833014 is an FDA 510(k) clearance for EBV-VCA-IGM IFA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 1 Immunology device with product code LJN cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K833014 · Zeus Scientific, Inc. · Immunology device
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Dec 1983
Decision
112d
Days
Class 1
Risk

K833014 is an FDA 510(k) clearance for the EBV-VCA-IGM IFA TEST SYSTEM. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 27, 1983 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.3235 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K833014

510(k) Number K833014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1983
Decision Date December 27, 1983
Days to Decision 112 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 104d · This submission: 112d
Pathway characteristics
Predicate-based equivalence.

LJN Device Classification - Class 1, General Controls

Product Code LJN Antibody Igm, If, Epstein-barr Virus
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.