Cleared Traditional

K914789 - ELISA CMV IGM

K914789 is the FDA 510(k) clearance for ELISA CMV IGM by Sclavo, Inc.. It is a Class 2 Microbiology device (product code LKQ) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K914789 · Sclavo, Inc. · Microbiology device
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Mar 1992
Decision
133d
Days
Class 2
Risk

K914789 is an FDA 510(k) clearance for the ELISA CMV IGM. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 133 days - within the typical 510(k) review window.

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: 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 Sclavo, Inc. devices

Submission Details

510(k) Number K914789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1991
Decision Date March 04, 1992
Days to Decision 133 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 102d · This submission: 133d
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 K914789.
IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,
K100433 · Siemens Healthcare Diagnostics · May 2010
VIDAS CMV IGM ASSAY
K933549 · Biomerieux Vitek, Inc. · Aug 1994
BARTELS CYTOMEGALOVIRUS IGM EIA
K922580 · Baxter Diagnostics, Inc. · Apr 1993
CMV-IGM IFA TEST SYSTEM
K900743 · Zeus Scientific, Inc. · Apr 1990
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