Cleared Traditional

K061338 - DIMENSION VISTA IGA FLEX REAGENT CARTRI...

K061338 is the FDA 510(k) clearance for DIMENSION VISTA IGA FLEX REAGENT CARTRI... by Dade Behring, Inc.. It is a Class 2 Immunology device (product code CFN) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K061338 · Dade Behring, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
52d
Days
Class 2
Risk

K061338 is an FDA 510(k) clearance for the DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY. 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 6, 2006 after a review of 52 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K061338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2006
Decision Date July 06, 2006
Days to Decision 52 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
52d faster than avg
Panel avg: 104d · This submission: 52d
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 K061338.
OLYMPUS IGG REAGENT
K073490 · Olympus America, Inc. · Feb 2008
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER
K072889 · The Binding Site, Ltd. · Feb 2008
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H
K061845 · Dade Behring, Inc. · Aug 2006
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM)
K042735 · Dade Behring, Inc. · Feb 2005
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS
K042475 · Ortho-Clinical Diagnostics, Inc. · Nov 2004
N LATEX IGM
K032014 · Dade Behring, Inc. · Aug 2003