Cleared Traditional

K100307 - GELSCAN, MODEL 1206

K100307 is an FDA 510(k) clearance for GELSCAN, manufactured by Sebia. The device is a Class 2 Chemistry device with product code CFE cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K100307 · Sebia · Chemistry device
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Aug 2010
Decision
209d
Days
Class 2
Risk

K100307 is an FDA 510(k) clearance for the GELSCAN, MODEL 1206. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by Sebia (Norcross, US). The FDA issued a Cleared decision on August 31, 2010 after a review of 209 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1445 - 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 Sebia devices

FDA 510(k) Submission Details - K100307

510(k) Number K100307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2010
Decision Date August 31, 2010
Days to Decision 209 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 88d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CFE Device Classification - Class 2, Special Controls

Product Code CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1445
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 - CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes

All 25
Devices cleared under the same product code (CFE) and FDA review panel - the closest regulatory comparables to K100307.
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K970477 · Sebia · Mar 1997
CARDIO REP LD
K940224 · Helena Laboratories · Aug 1994
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
K921455 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1992
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