Cleared Traditional

K081249 - DIMENSION VISTA SYSTEM A2MAC FLEX REAGE...

K081249 is the FDA 510(k) clearance for DIMENSION VISTA SYSTEM A2MAC FLEX REAGE... by Dade Behring, Inc.. It is a Class 2 Immunology device (product code DEB) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K081249 · Dade Behring, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
80d
Days
Class 2
Risk

K081249 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM P.... Classified as Alpha-2-macroglobulin, Antigen, Antiserum, Control (product code DEB), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 21, 2008 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5620 - 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 K081249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2008
Decision Date July 21, 2008
Days to Decision 80 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
24d faster than avg
Panel avg: 104d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEB Alpha-2-macroglobulin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5620
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 - DEB Alpha-2-macroglobulin, Antigen, Antiserum, Control

All 7
Devices cleared under the same product code (DEB) and FDA review panel - the closest regulatory comparables to K081249.
N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN
K053073 · Dade Behring, Inc. · Mar 2006
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT
K974564 · Beckman Instruments, Inc. · Feb 1998
ALPHA-2 MACROGLOBULIN TEST RID KIT
K914389 · The Binding Site, Ltd. · Dec 1991
QM300 ALPHA2 MACROGLOBULIN ANTIBODY PACK
K896483 · Kallestad Diag, A Div. of Erbamont, Inc. · Dec 1989
IMMUNOGL. FRCT. OF RABBIT ANTISER.-MACRO
K812493 · Dako Corp. · Sep 1981
HUMAN ALPHA2 MACROGLOBULIN
K791340 · Beckman Instruments, Inc. · Aug 1979