Cleared Traditional

K100525 - ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL 1 AND 2

K100525 is an FDA 510(k) clearance for ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL..., manufactured by Seppim S.A.S.. The device is a Class 2 Chemistry device with product code CGA cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K100525 · Seppim S.A.S. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
294d
Days
Class 2
Risk

K100525 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS GLUCOSE PAP SL ELITECH CLINICAL SYSTEMS ELICAL 2, E.... Classified as Glucose Oxidase, Glucose (product code CGA), Class II - Special Controls.

Submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on December 15, 2010 after a review of 294 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - 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 Seppim S.A.S. devices

FDA 510(k) Submission Details - K100525

510(k) Number K100525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2010
Decision Date December 15, 2010
Days to Decision 294 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
206d slower than avg
Panel avg: 88d · This submission: 294d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGA Device Classification - Class 2, Special Controls

Product Code CGA Glucose Oxidase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
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 - CGA Glucose Oxidase, Glucose

All 259
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