Cleared Traditional

K102959 - PROLYTE ELECTROLYTE ANALYZER

K102959 is an FDA 510(k) clearance for PROLYTE ELECTROLYTE ANALYZER, manufactured by Diamond Diagnostics, Inc.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K102959 · Diamond Diagnostics, Inc. · Chemistry device
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Jan 2011
Decision
101d
Days
Class 2
Risk

K102959 is an FDA 510(k) clearance for the PROLYTE ELECTROLYTE ANALYZER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on January 14, 2011 after a review of 101 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 Diamond Diagnostics, Inc. devices

FDA 510(k) Submission Details - K102959

510(k) Number K102959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 2010
Decision Date January 14, 2011
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
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 133
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K102959.
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
K123726 · Roche Diagnostics · May 2013
PROLYTE ELECTROLYTE ANALYZER
K121140 · Diamond Diagnostics, Inc. · Aug 2012
EASYRA SODIUM ASSAY, EASYRA POTASSIUM ASSAY, EASYRA CHLORIDE ASSAY, EASYRA CARBON DIOXIDE ASSAY MODEL CAT NO. 5423 & 520
K100829 · Medica Corp. · Jan 2011
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020
K100673 · Medica Corp. · Apr 2010
VITROS CHEMISTRY PRODUCTS NA + DT SLIDES, MODEL 153 2290 AND DT CALIBRATOR KIT, MODEL 195 7927
K091861 · Ortho-Clinical Diagnostics, Inc. · Sep 2009
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+
K082462 · Diamond Diagnostics, Inc. · Feb 2009