Cleared Traditional

K073634 - MULTIGENT CREATININE (ENZYMATIC) ASSAY

K073634 is an FDA 510(k) clearance for MULTIGENT CREATININE (ENZYMATIC) ASSAY, manufactured by SENTINEL CH. SpA. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K073634 · SENTINEL CH. SpA · Chemistry device
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Jun 2008
Decision
176d
Days
Class 2
Risk

K073634 is an FDA 510(k) clearance for the MULTIGENT CREATININE (ENZYMATIC) ASSAY. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on June 19, 2008 after a review of 176 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.

View all SENTINEL CH. SpA devices

FDA 510(k) Submission Details - K073634

510(k) Number K073634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date June 19, 2008
Days to Decision 176 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
88d slower than avg
Panel avg: 88d · This submission: 176d
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 47
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K073634.
SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
K091742 · Beckman Coulter, Inc. · Aug 2009
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
AFINION ACR AND ACR CONTROL
K072409 · Axis-Shield Poc AS · Feb 2008
DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270
K073055 · Dade Behring, Inc. · Jan 2008
CREATININE (ENZYMATIC)
K070824 · Thermofisher Scientific OY · Dec 2007