Cleared Traditional

K103376 - ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL

K103376 is an FDA 510(k) clearance for ELITECH CLINICAL SYSTEMS CREATINNE PAP ..., manufactured by Seppim S.A.S.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 366-day FDA review.

K103376 · Seppim S.A.S. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
366d
Days
Class 2
Risk

K103376 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL S.... Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on November 18, 2011 after a review of 366 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Seppim S.A.S. devices

FDA 510(k) Submission Details - K103376

510(k) Number K103376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2010
Decision Date November 18, 2011
Days to Decision 366 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
278d slower than avg
Panel avg: 88d · This submission: 366d
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 37
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K103376.
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