Cleared Traditional

K040971 - GENCHEM ISE ELECTROLYTE REFERENCE

K040971 is an FDA 510(k) clearance for GENCHEM ISE ELECTROLYTE REFERENCE, manufactured by Genchem, Inc.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K040971 · Genchem, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2004
Decision
252d
Days
Class 2
Risk

K040971 is an FDA 510(k) clearance for the GENCHEM ISE ELECTROLYTE REFERENCE. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Genchem, Inc. (Brea, US). The FDA issued a Cleared decision on December 22, 2004 after a review of 252 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 Genchem, Inc. devices

FDA 510(k) Submission Details - K040971

510(k) Number K040971 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2004
Decision Date December 22, 2004
Days to Decision 252 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
164d slower than avg
Panel avg: 88d · This submission: 252d
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 K040971.
TECO ISE REAGENT SET FOR CX SYSTEM
K052724 · Teco Diagnostics · Dec 2005
ISE INDIRECT NA, K, CL FOR GEN.2
K053165 · Roche Diagnostics Corp. · Dec 2005
ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH
K051646 · Pointe Scientific, Inc., · Oct 2005
SYNCHRON LX I 725 CLINICAL SYSTEM
K023049 · Beckman Coulter, Inc. · Oct 2002
PHOENIX ISE REAGENTS FOR BECKMAN CX SYSTEMS
K020364 · Phoenix Diagnostics, Inc. · Jun 2002
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213 · Beckman Coulter, Inc. · May 2001