← Back to catalogue

GelScan Model 1206

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K100307

by Sebia

Identifiers

510(k) Number
K100307 FDA 510(k)
FDA Product Code
CFE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1445 FDA 510(k)
Regulation Number
862.1445 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The GelScan Model 1206 is an electrophoretic device designed for the separation and analysis of lactate dehydrogenase isoenzymes. It operates using gel electrophoresis to differentiate isoenzyme patterns, aiding in clinical chemistry diagnostics for conditions such as myocardial infarction or liver disease.

This device is supplied as a reusable instrument and is intended for use in clinical laboratory settings. It is classified under FDA device class 2 and adheres to IVDR standards, with FDA 510(k) clearance (K100307) and a product code of CFE. Sterility and single-use status are not applicable, as it is a reusable analytical instrument.

Frequently asked questions

What clinical conditions is the GelScan Model 1206 primarily used to diagnose or monitor, and how does it work?

The GelScan Model 1206 is designed for analyzing lactate dehydrogenase (LD) isoenzymes through gel electrophoresis, which separates these proteins to reveal distinct patterns. This helps clinicians diagnose or monitor conditions like myocardial infarction (heart attack) or liver disease by identifying abnormal isoenzyme profiles linked to tissue damage or disease states.

Is the GelScan Model 1206 a single-use or reusable device, and what does that mean for maintenance?

The GelScan Model 1206 is a reusable instrument, meaning it is built for repeated use in clinical laboratory settings. Since it is not sterile or disposable, proper cleaning, calibration, and maintenance procedures must be followed to ensure accurate and reliable performance over time.

What type of laboratory setting is the GelScan Model 1206 intended for, and what regulatory standards does it comply with?

This device is specifically intended for use in clinical laboratory settings where electrophoretic analysis is performed. It complies with FDA 510(k) clearance (K100307) under the product code CFE, adhering to FDA Class 2 standards for clinical chemistry devices, and also meets In Vitro Diagnostic Regulation (IVDR) requirements.

How is the GelScan Model 1206 different from other electrophoretic devices, and what makes it suitable for lactate dehydrogenase analysis?

The GelScan Model 1206 is specialized for separating and analyzing lactate dehydrogenase isoenzymes using gel electrophoresis, a technique that differentiates protein patterns based on charge and size. Unlike general-purpose electrophoretic devices, it is optimized for clinical chemistry applications, particularly for diagnosing conditions like myocardial infarction or liver disease by providing precise isoenzyme profiles.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Sebia

Sources (2)

  • FDA 510(k) K100307 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026