Cleared Traditional

K852478 - ENZYGNOST + ANTI-CMV IGG TEST

K852478 is the FDA 510(k) clearance for ENZYGNOST + ANTI-CMV IGG TEST by Behring Diagnostics, Inc.. It is a Class 2 Microbiology device (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

Submission Details

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.

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 42
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K852478.
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
YBBOTT CMV TOTAL AB EIA
K832221 · Abbott Laboratories · Oct 1983
CORDIA CMV
K823123 · Cordis Corp. · Dec 1982