Cleared Traditional

K061251 - DIMENSION VISTA TOTAL IRON BINDING CAPA...

K061251 is the FDA 510(k) clearance for DIMENSION VISTA TOTAL IRON BINDING CAPA... by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIS) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K061251 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
27d
Days
Class 2
Risk

K061251 is an FDA 510(k) clearance for the DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR. Classified as Calibrator, Primary (product code JIS), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on May 31, 2006 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry 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 K061251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 2006
Decision Date May 31, 2006
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIS Calibrator, Primary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Chemistry devices follow this clearance model.

Regulatory Peers - JIS Calibrator, Primary

All 86
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K061251.
DIMENSION IRON CALIBRATOR
K060266 · Dade Behring, Inc. · Mar 2006
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
K053104 · Dade Behring, Inc. · Dec 2005
DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)
K032697 · Dade Behring, Inc. · Nov 2003
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORS
K032296 · Ortho-Clinical Diagnostics, Inc. · Aug 2003
CALIBRATION PLASMA LMW HEPARIN
K030964 · Instrumentation Laboratory CO · Jun 2003
WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
K030320 · Wako Chemicals USA, Inc. · Apr 2003