Cleared Traditional

K081161 - DIMENSION VISTA SYSTEM IGG FLEX REAGENT...

K081161 is the FDA 510(k) clearance for DIMENSION VISTA SYSTEM IGG FLEX REAGENT... by Dade Behring, Inc.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K081161 · Dade Behring, Inc. · Immunology device
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Jul 2008
Decision
95d
Days
Class 2
Risk

K081161 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PRO.... Classified as Method, Nephelometric, Immunoglobulins (g, A, M) (product code CFN), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 28, 2008 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K081161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2008
Decision Date July 28, 2008
Days to Decision 95 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 104d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFN Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 Immunology devices follow this clearance model.

Regulatory Peers - CFN Method, Nephelometric, Immunoglobulins (g, A, M)

All 42
Devices cleared under the same product code (CFN) and FDA review panel - the closest regulatory comparables to K081161.
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC
K083445 · Siemens Healthcare Diagnostics · Mar 2009
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
K082129 · The Binding Site, Ltd. · Feb 2009
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS
K081827 · The Binding Site, Ltd. · Dec 2008
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR
K073561 · Dade Behring, Inc. · Feb 2008
OLYMPUS IGM REAGENT
K073487 · Olympus America, Inc. · Feb 2008
OLYMPUS IGA REAGENT
K073489 · Olympus America, Inc. · Feb 2008