Cleared Traditional

K852478 - ENZYGNOST + ANTI-CMV IGG TEST

K852478 is an FDA 510(k) clearance for ENZYGNOST + ANTI-CMV IGG TEST, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LFZ cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K852478 · Behring Diagnostics, Inc. · Microbiology device
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Sep 1985
Decision
97d
Days
Class 2
Risk

K852478 is an FDA 510(k) clearance for the ENZYGNOST + ANTI-CMV IGG TEST. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 97 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K852478

510(k) Number K852478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1985
Decision Date September 16, 1985
Days to Decision 97 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
5d faster than avg
Panel avg: 102d · This submission: 97d
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 K852478.
MODIFIED DDI SEROCARD CMV IGG TEST KIT
K884248 · Disease Detection International, Inc. · Apr 1989
UBI MAGIWEL CMV IGG QUANTITATIVE
K883399 · United Biotech, Inc. · Mar 1989
SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT
K875361 · Disease Detection International, Inc. · May 1988
YBBOTT CMV TOTAL AB EIA
K832221 · Abbott Laboratories · Oct 1983
CORDIA CMV
K823123 · Cordis Corp. · Dec 1982