Cleared Traditional

K073634 - MULTIGENT CREATININE (ENZYMATIC) ASSAY (FDA 510(k) Clearance)

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

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

Submission Details

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
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.

Device Classification

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.