Cleared Traditional

K131605 - ELECSYS PRECICONTROL CMV IGG

K131605 is the FDA 510(k) clearance for ELECSYS PRECICONTROL CMV IGG by Roche Diagnostics. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K131605 · Roche Diagnostics · Microbiology device
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Feb 2014
Decision
270d
Days
Class 2
Risk

K131605 is an FDA 510(k) clearance for the ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY. 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 February 28, 2014 after a review of 270 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.

View all Roche Diagnostics devices

Submission Details

510(k) Number K131605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2013
Decision Date February 28, 2014
Days to Decision 270 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
168d slower than avg
Panel avg: 102d · This submission: 270d
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 31
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K131605.
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
IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6
K993952 · Diagnostic Products Corp. · Dec 1999
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K984139 · Zeus Scientific, Inc. · Jan 1999
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983803 · Zeus Scientific, Inc. · Dec 1998