Cleared Traditional

K883399 - UBI MAGIWEL CMV IGG QUANTITATIVE

K883399 is the FDA 510(k) clearance for UBI MAGIWEL CMV IGG QUANTITATIVE by United Biotech, Inc.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K883399 · United Biotech, Inc. · Microbiology device
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Mar 1989
Decision
228d
Days
Class 2
Risk

K883399 is an FDA 510(k) clearance for the UBI MAGIWEL CMV IGG QUANTITATIVE. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by United Biotech, Inc. (Mountain View, US). The FDA issued a Cleared decision on March 27, 1989 after a review of 228 days - an extended review 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: 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 United Biotech, Inc. devices

Submission Details

510(k) Number K883399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1988
Decision Date March 27, 1989
Days to Decision 228 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
126d slower than avg
Panel avg: 102d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFZ Enzyme Linked Immunoabsorbent Assay, 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 - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 43
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K883399.
VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM
K890610 · Organon Teknika Corp. · Jun 1989
CMV ELISA TEST SYSTEM
K891081 · Zeus Scientific, Inc. · Jun 1989
CMV-CUBE(TM)
K884842 · Difco Laboratories, Inc. · Apr 1989
ENZYGNOST + ANTI-CMV IGG TEST
K852478 · Behring Diagnostics, Inc. · Sep 1985
YBBOTT CMV TOTAL AB EIA
K832221 · Abbott Laboratories · Oct 1983
CORDIA CMV
K823123 · Cordis Corp. · Dec 1982