Cleared Traditional

K883399 - UBI MAGIWEL CMV IGG QUANTITATIVE

K883399 is an FDA 510(k) clearance for UBI MAGIWEL CMV IGG QUANTITATIVE, manufactured by United Biotech, Inc.. The device is a Class 2 Microbiology device with 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

FDA 510(k) Submission Details - K883399

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
Combination Product No
PCCP Authorized No
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.

LFZ Device Classification - Class 2, Special Controls

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 50
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K883399.
CMV ELISA TEST SYSTEM
K891081 · Zeus Scientific, Inc. · Jun 1989
CMV-CUBE(TM)
K884842 · Difco Laboratories, Inc. · Apr 1989
MODIFIED DDI SEROCARD CMV IGG TEST KIT
K884248 · Disease Detection International, Inc. · Apr 1989
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
K875361 · Disease Detection International, Inc. · May 1988
ENZYGNOST + ANTI-CMV IGG TEST
K852478 · Behring Diagnostics, Inc. · Sep 1985
YBBOTT CMV TOTAL AB EIA
K832221 · Abbott Laboratories · Oct 1983