Cleared Traditional

K893466 - CMV IGM ANTIBODY TEST (INDIRECT ENZYME ...

K893466 is the FDA 510(k) clearance for CMV IGM ANTIBODY TEST (INDIRECT ENZYME ... by Immuno Concepts, Inc.. It is a Class 2 Microbiology device (product code LKQ) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K893466 · Immuno Concepts, Inc. · Microbiology device
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Jul 1989
Decision
72d
Days
Class 2
Risk

K893466 is an FDA 510(k) clearance for the CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST). Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Immuno Concepts, Inc. (Sacramento, US). The FDA issued a Cleared decision on July 14, 1989 after a review of 72 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 Immuno Concepts, Inc. devices

Submission Details

510(k) Number K893466 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1989
Decision Date July 14, 1989
Days to Decision 72 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
30d faster than avg
Panel avg: 102d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LKQ Antibody Igm,if, Cytomegalovirus Virus
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 - LKQ Antibody Igm,if, Cytomegalovirus Virus

All 11
Devices cleared under the same product code (LKQ) and FDA review panel - the closest regulatory comparables to K893466.
ELISA CMV IGM
K914789 · Sclavo, Inc. · Mar 1992
CMV-IGM IFA TEST SYSTEM
K900743 · Zeus Scientific, Inc. · Apr 1990
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · Immuno Concepts, Inc. · Jul 1989
ABBOTT CMV-M EIA KIT
K872881 · Abbott Laboratories · May 1988
CMV IGM MICROASSAY
K871832 · Diamedix Corp. · Aug 1987
ENZYGNOST ANTI-CMV IGM TEST
K861363 · Behring Diagnostics, Inc. · Jul 1986