Cleared Traditional

K061390 - DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR

K061390 is the FDA 510(k) clearance for DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIX) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K061390 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
48d
Days
Class 2
Risk

K061390 is an FDA 510(k) clearance for the DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on July 5, 2006 after a review of 48 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 K061390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2006
Decision Date July 05, 2006
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
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 - JIX Calibrator, Multi-analyte Mixture

All 175
Devices cleared under the same product code (JIX) and FDA review panel - the closest regulatory comparables to K061390.
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
K062055 · Dade Behring, Inc. · Aug 2006
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
K061703 · Dade Behring, Inc. · Aug 2006
RANDOX LIQUID PROTEIN CALIBRATOR
K061056 · Randox Laboratories, Ltd. · Jul 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
K061218 · Dade Behring, Inc. · Jun 2006
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
K060940 · Ortho-Clinical Diagnostics, Inc. · Apr 2006
RANDOX CALIBRATION SERUM
K053153 · Randox Laboratories, Ltd. · Jan 2006