Cleared Traditional

K072409 - AFINION ACR AND ACR CONTROL

K072409 is an FDA 510(k) clearance for AFINION ACR AND ACR CONTROL, manufactured by Axis-Shield Poc AS. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K072409 · Axis-Shield Poc AS · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
169d
Days
Class 2
Risk

K072409 is an FDA 510(k) clearance for the AFINION ACR AND ACR CONTROL. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Axis-Shield Poc AS (Rodelokka, Oslo, NO). The FDA issued a Cleared decision on February 12, 2008 after a review of 169 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K072409

510(k) Number K072409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 2007
Decision Date February 12, 2008
Days to Decision 169 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
80d slower than avg
Panel avg: 89d · This submission: 169d
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 K072409.
DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270
K090330 · Siemens Healthcare Diagnostics, Inc. · May 2009
S-TEST CREATININE (CRE)
K080073 · Alfa Wassermann, Inc. · Jun 2008
MULTIGENT CREATININE (ENZYMATIC) ASSAY
K073634 · SENTINEL CH. SpA · Jun 2008
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · Dade Behring, Inc. · Jan 2008
CREATININE (ENZYMATIC)
K070824 · Thermofisher Scientific OY · Dec 2007
ADVIA CHEMISTRY ENZYMATIC CREATININE_2
K070727 · Siemens Medical Solutions Diagnostics · Aug 2007
K072409 · AFINION ACR AND ACR CONTROL
Download PDF FDA Summary Axis-Shield Poc AS