Cleared Traditional

K010208 - DIMENSION ENZYMATIC CARBONATE (ECO2) CA...

K010208 is the FDA 510(k) clearance for DIMENSION ENZYMATIC CARBONATE (ECO2) CA... by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K010208 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
28d
Days
Class 2
Risk

K010208 is an FDA 510(k) clearance for the DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on February 20, 2001 after a review of 28 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 K010208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2001
Decision Date February 20, 2001
Days to Decision 28 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
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JIT Calibrator, Secondary
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 - JIT Calibrator, Secondary

All 145
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K010208.
DIMENSION CTNI CALIBRATOR
K010314 · Dade Behring, Inc. · Apr 2001
N PROTEIN STANDARD UY CALIBRATOR
K003501 · Dade Behring, Inc. · Mar 2001
ELECSYS TESTOSTERONE CALSET II
K003411 · Roche Diagnostics Corp. · Mar 2001
ELECSYS FSH CALSET II
K003409 · Roche Diagnostics Corp. · Jan 2001
ACCESS ULTRASENSITIVE HGH CALIBRATORS
K003098 · Beckman Coulter, Inc. · Nov 2000
DIMENSION SPECIAL PROTEIN CALIBRATOR
K994291 · Dade Behring, Inc. · Mar 2000