Cleared Traditional

K874185 - DART ELECTROLYTE REAGENT SYSTEM

K874185 is the FDA 510(k) clearance for DART ELECTROLYTE REAGENT SYSTEM by Coulter Electronics, Inc.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K874185 · Coulter Electronics, Inc. · Chemistry device
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Nov 1987
Decision
21d
Days
Class 2
Risk

K874185 is an FDA 510(k) clearance for the DART (R) ELECTROLYTE REAGENT SYSTEM. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on November 4, 1987 after a review of 21 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Coulter Electronics, Inc. devices

Submission Details

510(k) Number K874185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date November 04, 1987
Days to Decision 21 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 88d · This submission: 21d
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 111
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K874185.
NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
K881255 · Nova Biomedical Corp. · May 1988
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K874832 · Nova Biomedical Corp. · Feb 1988
ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)
K875263 · Technicon Instruments Corp. · Feb 1988
SODIUM AND POTASSIUM BY ION SELECTIVE
K873074 · American Monitor Corp. · Oct 1987
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE
K872716 · Ciba Corning Diagnostics Corp. · Jul 1987
NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K872190 · Nova Biomedical Corp. · Jun 1987