Cleared Traditional

K140373 - ISE INDIRECT NA, K, C1 FOR GEN 2

K140373 is an FDA 510(k) clearance for ISE INDIRECT NA, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K140373 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
97d
Days
Class 2
Risk

K140373 is an FDA 510(k) clearance for the ISE INDIRECT NA, K, C1 FOR GEN 2. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on May 22, 2014 after a review of 97 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.

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FDA 510(k) Submission Details - K140373

510(k) Number K140373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date May 22, 2014
Days to Decision 97 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
9d slower than avg
Panel avg: 88d · This submission: 97d
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 131
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K140373.
i-STAT Alinity System with i-STAT Sodium test
K153357 · Abbott Point of Care, Inc. · Jul 2016
BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer
K160370 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jun 2016
Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator
K151767 · Siemens Healthcare Diagnostics, Inc. · Dec 2015
COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2
K132418 · Roche Diagnostics · Dec 2013
COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2
K123726 · Roche Diagnostics · May 2013
PROLYTE ELECTROLYTE ANALYZER
K121140 · Diamond Diagnostics, Inc. · Aug 2012