Cleared Traditional

EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590 (K883870) - FDA 510(k) Clearance

Class I Microbiology device.

K883870 · Clinical Sciences, Inc. · Microbiology device
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Jul 1989
Decision
304d
Days
Class 1
Risk

K883870 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Clinical Sciences, Inc. (Whippany, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K883870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1988
Decision Date July 14, 1989
Days to Decision 304 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 102d · This submission: 304d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.