Cleared Traditional

K962334 - EML105 ELECTROLYTE METABOLITE ANALYZER

K962334 is an FDA 510(k) clearance for EML105 ELECTROLYTE METABOLITE ANALYZER, manufactured by Radiometer America, Inc.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K962334 · Radiometer America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1996
Decision
129d
Days
Class 2
Risk

K962334 is an FDA 510(k) clearance for the EML105 ELECTROLYTE METABOLITE ANALYZER. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Radiometer America, Inc. (Westlake, US). The FDA issued a Cleared decision on October 24, 1996 after a review of 129 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 Radiometer America, Inc. devices

FDA 510(k) Submission Details - K962334

510(k) Number K962334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1996
Decision Date October 24, 1996
Days to Decision 129 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
41d slower than avg
Panel avg: 88d · This submission: 129d
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 129
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K962334.
BAYER ADVIA 1650 CHEMISTRY SYSTEM
K990346 · Bayer Corp. · May 1999
CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
K990036 · Careside, Inc. · Mar 1999
EASYLYTE SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K963763 · Medica Corp. · Nov 1996
(MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE
K963627 · Roche Diagnostic Systems, Inc. · Oct 1996
SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT
K963542 · Sigma Diagnostics, Inc. · Sep 1996
EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+)
K961099 · Johnson & Johnson Clinical Diagnostics, Inc. · May 1996