Cleared Traditional

K102647 - ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/GOT 4+1 SL/POTASSIUM, SODIUM, CHLORIDE...

K102647 is an FDA 510(k) clearance for ELITECH CLINICAL SYSTEMS SELECTRA PROM/..., manufactured by Elitechgroup Vital Scientific BV. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 191-day FDA review.

K102647 · Elitechgroup Vital Scientific BV · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2011
Decision
191d
Days
Class 2
Risk

K102647 is an FDA 510(k) clearance for the ELITECH CLINICAL SYSTEMS SELECTRA PROM/ELICAL 2/ELITROL I AND ELITROL II/AST/.... Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Elitechgroup Vital Scientific BV (Bothell, US). The FDA issued a Cleared decision on March 24, 2011 after a review of 191 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1665 - 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 Elitechgroup Vital Scientific BV devices

FDA 510(k) Submission Details - K102647

510(k) Number K102647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2010
Decision Date March 24, 2011
Days to Decision 191 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
103d slower than avg
Panel avg: 88d · This submission: 191d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JGS Device Classification - Class 2, Special Controls

Product Code JGS Electrode, Ion Specific, Sodium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1665
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 - JGS Electrode, Ion Specific, Sodium

All 132
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K102647.
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K100673 · Medica Corp. · Apr 2010