Cleared Traditional

K910003 - CYTOMEGALOVIRUS ANTIBODY SCREEN

K910003 is an FDA 510(k) clearance for CYTOMEGALOVIRUS ANTIBODY SCREEN, manufactured by Immucor, Inc.. The device is a Class 2 Microbiology device with product code LJO cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K910003 · Immucor, Inc. · Microbiology device
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Mar 1991
Decision
77d
Days
Class 2
Risk

K910003 is an FDA 510(k) clearance for the CYTOMEGALOVIRUS ANTIBODY SCREEN. Classified as Antigen, Iha, Cytomegalovirus (product code LJO), Class II - Special Controls.

Submitted by Immucor, Inc. (Norcross, US). The FDA issued a Cleared decision on March 20, 1991 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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 Immucor, Inc. devices

FDA 510(k) Submission Details - K910003

510(k) Number K910003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1991
Decision Date March 20, 1991
Days to Decision 77 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 102d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJO Device Classification - Class 2, Special Controls

Product Code LJO Antigen, Iha, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LJO Antigen, Iha, Cytomegalovirus

All 7
Devices cleared under the same product code (LJO) and FDA review panel - the closest regulatory comparables to K910003.
DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM
K001767 · Diamedix Corp. · Aug 2000
CMVGEN
K974456 · Instrumentation Laboratory CO · May 1998
ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
K951851 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1996
CMV-IHA
K852494 · Hillcrest Biologicals · Sep 1985
CMV LATEX AGGLUTINATION TEST KIT
K841520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984