Cleared Traditional

K895707 - EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME...

K895707 is the FDA 510(k) clearance for EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME... by Immuno Concepts, Inc.. It is a Class 1 Microbiology device (product code LLM) cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K895707 · Immuno Concepts, Inc. · Microbiology device
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Dec 1989
Decision
74d
Days
Class 1
Risk

K895707 is an FDA 510(k) clearance for the EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY). Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), Class I - General Controls.

Submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on December 8, 1989 after a review of 74 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Immuno Concepts, Inc. devices

Submission Details

510(k) Number K895707 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1989
Decision Date December 08, 1989
Days to Decision 74 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
28d faster than avg
Panel avg: 102d · This submission: 74d
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 12
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K895707.
ORTHO*EPSTEIN-BARR VIRUS EBNA-IFF ANTIBODY ELISA
K930002 · Ortho Diagnostic Systems, Inc. · Jul 1993
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
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
EBV-NA TEST
K880043 · Gull Laboratories, Inc. · Mar 1988