Cleared Traditional

K900743 - CMV-IGM IFA TEST SYSTEM

K900743 is an FDA 510(k) clearance for CMV-IGM IFA TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Microbiology device with product code LKQ cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K900743 · Zeus Scientific, Inc. · Microbiology device
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Apr 1990
Decision
69d
Days
Class 2
Risk

K900743 is an FDA 510(k) clearance for the CMV-IGM IFA TEST SYSTEM. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on April 26, 1990 after a review of 69 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K900743

510(k) Number K900743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1990
Decision Date April 26, 1990
Days to Decision 69 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
33d faster than avg
Panel avg: 102d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKQ Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (LKQ) and FDA review panel - the closest regulatory comparables to K900743.
VIDAS CMV IGM ASSAY
K933549 · Biomerieux Vitek, Inc. · Aug 1994
BARTELS CYTOMEGALOVIRUS IGM EIA
K922580 · Baxter Diagnostics, Inc. · Apr 1993
ELISA CMV IGM
K914789 · Sclavo, Inc. · Mar 1992
CMV IGM ANTIBODY TEST (INDIRECT FLUORESCENT TEST)
K893465 · Immuno Concepts, Inc. · Jul 1989
CMV IGM ANTIBODY TEST (INDIRECT ENZYME TEST)
K893466 · Immuno Concepts, Inc. · Jul 1989
ABBOTT CMV-M EIA KIT
K872881 · Abbott Laboratories · May 1988