Cleared Traditional

K901485 - ENZYGNOST ANTI-CMV/IGG + IGM

K901485 is the FDA 510(k) clearance for ENZYGNOST ANTI-CMV/IGG + IGM by Behring Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 417-day FDA review.

K901485 · Behring Diagnostics, Inc. · Microbiology device
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May 1991
Decision
417d
Days
Class 2
Risk

K901485 is an FDA 510(k) clearance for the ENZYGNOST ANTI-CMV/IGG + IGM. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on May 20, 1991 after a review of 417 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K901485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1990
Decision Date May 20, 1991
Days to Decision 417 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
315d slower than avg
Panel avg: 102d · This submission: 417d
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 K901485.
ENZYGNOST(R) ANTI-CMV IGG
K913910 · Behring Diagnostics, Inc. · Apr 1992
ENZYGNOST(R) ANTI-CMV/IGM
K913693 · Behring Diagnostics, Inc. · Feb 1992
CMV IGG ELISA TEST
K915892 · Gull Laboratories, Inc. · Feb 1992
CMV IGM ELISA TEST
K903807 · Gull Laboratories, Inc. · Dec 1990
ORTHO CMV-M ANTIBODY ELISA TEST
K905077 · Ortho Diagnostic Systems, Inc. · Dec 1990
ORTHO CMV-G ANTIBODY ELISA TEST
K905078 · Ortho Diagnostic Systems, Inc. · Dec 1990