Cleared Traditional

K093883 - AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-

K093883 is an FDA 510(k) clearance for AST/GOT 4+1 SL, manufactured by Seppim S.A.S.. The device is a Class 2 Chemistry device with product code CIT cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K093883 · Seppim S.A.S. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
276d
Days
Class 2
Risk

K093883 is an FDA 510(k) clearance for the AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0.... Classified as Nadh Oxidation/nad Reduction, Ast/sgot (product code CIT), Class II - Special Controls.

Submitted by Seppim S.A.S. (Bothell, US). The FDA issued a Cleared decision on September 20, 2010 after a review of 276 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1100 - 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 - K093883

510(k) Number K093883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2009
Decision Date September 20, 2010
Days to Decision 276 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
188d slower than avg
Panel avg: 88d · This submission: 276d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIT Device Classification - Class 2, Special Controls

Product Code CIT Nadh Oxidation/nad Reduction, Ast/sgot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1100
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 - CIT Nadh Oxidation/nad Reduction, Ast/sgot

All 131
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