Cleared Traditional

K883870 - EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590

K883870 is an FDA 510(k) clearance for EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590, manufactured by Clinical Sciences, Inc.. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 304-day FDA review.

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

FDA 510(k) Submission Details - K883870

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
202d slower than avg
Panel avg: 102d · This submission: 304d
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 47
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K883870.
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K894235 · Whittaker Bioproducts, Inc. · Aug 1989
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K883871 · Clinical Sciences, Inc. · Jul 1989
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K882447 · Zeus Scientific, Inc. · Dec 1988