Cleared Traditional

Elecsys CMV IgM (K163569) - FDA 510(k) Clearance

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

K163569 · Roche Diagnostics · Microbiology device
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Mar 2017
Decision
88d
Days
Class 2
Risk

K163569 is an FDA 510(k) clearance for the Elecsys CMV IgM. 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 March 17, 2017 after a review of 88 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K163569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2016
Decision Date March 17, 2017
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
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 28
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K163569.
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
ELECYS CMV IGM IMMUNOASSAY
K142133 · Roche Diagnostics · Oct 2014
ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY
K131605 · Roche Diagnostics · Feb 2014
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952 · Diagnostic Products Corp. · Dec 1999