Cleared Traditional

K042118 - ATHENA MULTI-LYTE EBV IGG TEST SYSTEM

K042118 is an FDA 510(k) clearance for ATHENA MULTI-LYTE EBV IGG TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 1 Microbiology device with product code JRY cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K042118 · Zeus Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
266d
Days
Class 1
Risk

K042118 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE EBV IGG TEST SYSTEM. Classified as Antiserum, Fluorescent, Epstein-barr Virus (product code JRY), Class I - General Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on April 29, 2005 after a review of 266 days - an extended review 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: 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 - K042118

510(k) Number K042118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2004
Decision Date April 29, 2005
Days to Decision 266 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
164d slower than avg
Panel avg: 102d · This submission: 266d
Pathway characteristics
Predicate-based equivalence.

JRY Device Classification - Class 1, General Controls

Product Code JRY Antiserum, Fluorescent, 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.