Cleared Traditional

K951549 - EBNA IGG EIA TEST SYSTEM

K951549 is an FDA 510(k) clearance for EBNA IGG EIA TEST SYSTEM, manufactured by Immunoprobe, Inc.. The device is a Class 1 Microbiology device with product code LLM cleared through the Traditional 510(k) pathway after a 391-day FDA review.

K951549 · Immunoprobe, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1996
Decision
391d
Days
Class 1
Risk

K951549 is an FDA 510(k) clearance for the EBNA IGG EIA TEST SYSTEM. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Immunoprobe, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on April 29, 1996 after a review of 391 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 Immunoprobe, Inc. devices

FDA 510(k) Submission Details - K951549

510(k) Number K951549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1995
Decision Date April 29, 1996
Days to Decision 391 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
289d slower than avg
Panel avg: 102d · This submission: 391d
Pathway characteristics
Predicate-based equivalence.

LLM Device Classification - Class 1, General Controls

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 20
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K951549.
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