Cleared Traditional

ELITECH CLINICAL SYSTEMS CREATINNE PAP SL MODEL CRSL-0250, CLITECH CLINICAL SYSTEMS ELICAL 2 MODEL CALI-0580, ELITECH CL (K103376) - FDA 510(k) Clearance

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

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

Submission Details

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.

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.

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 K103376.
QSCHECK UISACR
K252619 · Qstag, Inc. · Feb 2026
Atellica CH Enzymatic Creatinine_3 (ECre3)
K212223 · Siemens Healthcare Diagnostics, Inc. · Nov 2021
Yumizen C1200 Creatinine PAP
K193649 · HORIBA ABX SAS · May 2021
ACR LAB Urine Analysis Test System
K182384 · Healthy.Io, Ltd. · Jul 2019
GEM Premier ChemSTAT
K183555 · Instrumentation Laboratory CO · Feb 2019
URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer
K182038 · Yd Diagnostics Corporation · Dec 2018