Cleared Traditional

K073055 - DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270

K073055 is an FDA 510(k) clearance for DIMENSION ENZYMATIC CREATININE FLEX REA..., manufactured by Dade Behring, Inc.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K073055 · Dade Behring, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2008
Decision
65d
Days
Class 2
Risk

K073055 is an FDA 510(k) clearance for the DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on January 3, 2008 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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.

FDA 510(k) Submission Details - K073055

510(k) Number K073055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2007
Decision Date January 03, 2008
Days to Decision 65 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
23d faster than avg
Panel avg: 88d · This submission: 65d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - JFY Enzymatic Method, Creatinine

All 48
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K073055.
S-TEST CREATININE (CRE)
K080073 · Alfa Wassermann, Inc. · Jun 2008
MULTIGENT CREATININE (ENZYMATIC) ASSAY
K073634 · SENTINEL CH. SpA · Jun 2008
AFINION ACR AND ACR CONTROL
K072409 · Axis-Shield Poc AS · Feb 2008
CREATININE (ENZYMATIC)
K070824 · Thermofisher Scientific OY · Dec 2007
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
K070727 · Siemens Medical Solutions Diagnostics · Aug 2007
ENZYMATIC CREATININE ASSAY (265 SERIES)
K070383 · Diagnostic Chemicals , Ltd. · Jun 2007
K073055 · DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
Download PDF FDA Summary Dade Behring, Inc.