Cleared Traditional

K925690 - MERIDIAN EBNA TEST KIT

K925690 is an FDA 510(k) clearance for MERIDIAN EBNA TEST KIT, manufactured by Fuller Laboratories, Inc.. The device is a Class 1 Microbiology device with product code LLM cleared through the Traditional 510(k) pathway after a 334-day FDA review.

K925690 · Fuller Laboratories, Inc. · Microbiology device
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Oct 1993
Decision
334d
Days
Class 1
Risk

K925690 is an FDA 510(k) clearance for the MERIDIAN EBNA TEST KIT. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Fuller Laboratories, Inc. (Fullerton, US). The FDA issued a Cleared decision on October 12, 1993 after a review of 334 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 Fuller Laboratories, Inc. devices

FDA 510(k) Submission Details - K925690

510(k) Number K925690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1992
Decision Date October 12, 1993
Days to Decision 334 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
232d slower than avg
Panel avg: 102d · This submission: 334d
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 22
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K925690.
EBNA IGG ELISA TEST
K935730 · Gull Laboratories, Inc. · Sep 1995
INCSTAR EPSTEIN-BARR NUCLEAR ANTIGEN (EBNA_ IGG ELISA KIT
K946158 · Incstar Corp. · Jun 1995
EBNA IGG ELISA TEST SYSTEM
K932742 · Zeus Scientific, Inc. · May 1995
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
K930002 · Ortho Diagnostic Systems, Inc. · Jul 1993
EBNA STAT TEST KIT
K911473 · Whittaker Bioproducts, Inc. · Sep 1991
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
K911569 · Ortho Diagnostic Systems, Inc. · Jun 1991