Cleared Traditional

K051646 - ISE DILUENT

K051646 is the FDA 510(k) clearance for ISE DILUENT by Pointe Scientific, Inc.,. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K051646 · Pointe Scientific, Inc., · Chemistry device
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Oct 2005
Decision
108d
Days
Class 2
Risk

K051646 is an FDA 510(k) clearance for the ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Lincoln Park, US). The FDA issued a Cleared decision on October 7, 2005 after a review of 108 days - within the typical 510(k) review window.

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 Pointe Scientific, Inc., devices

Submission Details

510(k) Number K051646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2005
Decision Date October 07, 2005
Days to Decision 108 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
20d slower than avg
Panel avg: 88d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 108
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K051646.
VITROS CHEMISTRY PRODUCT NA+ SLIDES
K081411 · Ortho-Clinical Diagnostics, Inc. · Jun 2008
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
SYNCHRON LX I 725 CLINICAL SYSTEM
K023049 · Beckman Coulter, Inc. · Oct 2002
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
K011213 · Beckman Coulter, Inc. · May 2001
EASYELECTROLYTE NA/K/LI ANALYZER & RAPIDLYTE NA/K/LI ANALYZER
K002407 · Medica Corp. · Feb 2001