Cleared Traditional

K883601 - EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #...

K883601 is the FDA 510(k) clearance for EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #... by Clinical Sciences, Inc.. It is a Class 1 Microbiology device (product code LLM) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K883601 · Clinical Sciences, Inc. · Microbiology device
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May 1989
Decision
261d
Days
Class 1
Risk

K883601 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Clinical Sciences, Inc. (Whippany, US). The FDA issued a Cleared decision on May 11, 1989 after a review of 261 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 Clinical Sciences, Inc. devices

Submission Details

510(k) Number K883601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1988
Decision Date May 11, 1989
Days to Decision 261 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
159d slower than avg
Panel avg: 102d · This submission: 261d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LLM Test, Antigen, Nuclear, 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.

Regulatory Peers - LLM Test, Antigen, Nuclear, Epstein-barr Virus

All 14
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K883601.
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
K911569 · Ortho Diagnostic Systems, Inc. · Jun 1991
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
K895708 · Immuno Concepts, Inc. · Dec 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
K895707 · Immuno Concepts, Inc. · Dec 1989
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST
K882440 · Zeus Scientific, Inc. · Dec 1988
DU PONT EBNA-IGG ANTIBODY ELISA KIT
K875203 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1988
EBNA ANTIBODY
K875170 · Hillcrest Biologicals · May 1988