Cleared Traditional

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) (K032697) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K032697 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
66d
Days
Class 2
Risk

K032697 is an FDA 510(k) clearance for the DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414). 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 November 7, 2003 after a review of 66 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 K032697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2003
Decision Date November 07, 2003
Days to Decision 66 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
22d faster than avg
Panel avg: 88d · This submission: 66d
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 129
Devices cleared under the same product code (JIS) and FDA review panel - the closest regulatory comparables to K032697.
DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR
K061251 · Dade Behring, Inc. · May 2006
DIMENSION IRON CALIBRATOR
K060266 · Dade Behring, Inc. · Mar 2006
DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR
K053104 · Dade Behring, Inc. · Dec 2005
N LP(A) STANDARD SY
K013126 · Dade Behring, Inc. · Nov 2001
DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
K994114 · Dade Behring, Inc. · Jan 2000
IMX ESTRADIOL
K951629 · Abbott Laboratories · May 1995