Cleared Traditional

K220911 - Elecsys CMV IgG

K220911 is an FDA 510(k) clearance for Elecsys CMV IgG, manufactured by Roche Diagnostics. The device is a Class 2 Microbiology device with product code LFZ cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K220911 · Roche Diagnostics · Microbiology device
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Oct 2022
Decision
197d
Days
Class 2
Risk

K220911 is an FDA 510(k) clearance for the Elecsys CMV IgG. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on October 12, 2022 after a review of 197 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.

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FDA 510(k) Submission Details - K220911

510(k) Number K220911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2022
Decision Date October 12, 2022
Days to Decision 197 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 102d · This submission: 197d
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 K220911.
Architect CMV IgG
K220949 · Abbott Laboratories · 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
LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set
K162969 · DiaSorin, Inc. · Jan 2017
ELECYS CMV IGM IMMUNOASSAY
K142133 · Roche Diagnostics · Oct 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
K131605 · Roche Diagnostics · Feb 2014