Cleared Traditional

K915348 - EBV-VCA IGM ELISA

K915348 is an FDA 510(k) clearance for EBV-VCA IGM ELISA, manufactured by Pharmacia Diagnostics, Inc.. The device is a Class 1 Microbiology device with product code LJN cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K915348 · Pharmacia Diagnostics, Inc. · Microbiology device
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Feb 1992
Decision
80d
Days
Class 1
Risk

K915348 is an FDA 510(k) clearance for the EBV-VCA IGM ELISA. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Pharmacia Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on February 14, 1992 after a review of 80 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.

FDA 510(k) Submission Details - K915348

510(k) Number K915348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date February 14, 1992
Days to Decision 80 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
22d faster than avg
Panel avg: 102d · This submission: 80d
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 23
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K915348.
EPSTEIN-BARR VIRUS VCA (IGM) RECOMB IMMUN ANTIBODY
K931520 · Mrl Diagnostics · Apr 1994
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
K930020 · Ortho Diagnostic Systems, Inc. · Jul 1993
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331 · Baxter Diagnostics, Inc. · Sep 1992
AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST
K911362 · Amico Laboratories, Inc. · Oct 1991
EBV IGM ELISA TEST
K910042 · Gull Laboratories, Inc. · Feb 1991
(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM
K901840 · Granbio, Inc. · Sep 1990
K915348 · EBV-VCA IGM ELISA
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