Cleared Traditional

ENZYGNOST ANTI-CMV/IGG + IGM (K901485) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K901485 · Behring Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 57
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K901485.
Architect CMV IgG
K220949 · Abbott Laboratories · Oct 2022
Elecsys CMV IgG
K220911 · Roche Diagnostics · Oct 2022
ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control
K181213 · Siemens Healthcare Diagnostics, Inc. · Jul 2018
Elecsys CMV IgM
K163569 · Roche Diagnostics · Mar 2017
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952 · Diagnostic Products Corp. · Dec 1999
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · Abbott Laboratories · Mar 1997