Cleared Traditional

K880886 - EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)

K880886 is an FDA 510(k) clearance for EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUOR..., manufactured by Immuno Concepts, Inc.. The device is a Class 1 Microbiology device with product code LJN cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K880886 · Immuno Concepts, Inc. · Microbiology device
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Aug 1988
Decision
181d
Days
Class 1
Risk

K880886 is an FDA 510(k) clearance for the EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT). Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on August 30, 1988 after a review of 181 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Immuno Concepts, Inc. devices

FDA 510(k) Submission Details - K880886

510(k) Number K880886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1988
Decision Date August 30, 1988
Days to Decision 181 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
79d slower than avg
Panel avg: 102d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

LJN Device Classification - Class 1, General Controls

Product Code LJN Antibody Igm, If, 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 - LJN Antibody Igm, If, Epstein-barr Virus

All 15
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K880886.
EBV VCA ANTIBODY (IGM)
K896594 · Hillcrest Biologicals · Jan 1990
RESUBMITTED EBV/IGM-CHECK TEST KIT
K890639 · Diagnostic Technology, Inc. · Jun 1989
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
K880884 · Immuno Concepts, Inc. · Aug 1988
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1988
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
K872541 · Ortho Diagnostic Systems, Inc. · May 1988
EBV-VCA-IGM IFA TEST SYSTEM
K833014 · Zeus Scientific, Inc. · Dec 1983