Cleared Traditional

K961099 - EKTACHEM CLINICAL CHEMISTRY SLIDE SODIU...

K961099 is the FDA 510(k) clearance for EKTACHEM CLINICAL CHEMISTRY SLIDE SODIU... by Johnson & Johnson Clinical Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K961099 · Johnson & Johnson Clinical Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1996
Decision
49d
Days
Class 2
Risk

K961099 is an FDA 510(k) clearance for the EKTACHEM CLINICAL CHEMISTRY SLIDE SODIUM (NA+). Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Johnson & Johnson Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on May 7, 1996 after a review of 49 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 Johnson & Johnson Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K961099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1996
Decision Date May 07, 1996
Days to Decision 49 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
39d faster than avg
Panel avg: 88d · This submission: 49d
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 115
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K961099.
EML105 ELECTROLYTE METABOLITE ANALYZER
K962334 · Radiometer America, Inc. · Oct 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
EASYSTAT SODIUM/POTASSIUM/CHLORIDE ANALYZER
K955374 · Medica Corp. · Feb 1996
EASYSTAT SODIUM/POTASSIUM ANALYZER
K955375 · Medica Corp. · Feb 1996
SYNERMED ISE REAGENTS
K952179 · Synermed, Inc. · Jun 1995