Cleared Traditional

K963542 - SIGMA DIAGOSTIC ELECTROLYTE REFERENCE R...

K963542 is the FDA 510(k) clearance for SIGMA DIAGOSTIC ELECTROLYTE REFERENCE R... by Sigma Diagnostics, Inc.. It is a Class 2 Chemistry device (product code JGS) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K963542 · Sigma Diagnostics, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
23d
Days
Class 2
Risk

K963542 is an FDA 510(k) clearance for the SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 27, 1996 after a review of 23 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 Sigma Diagnostics, Inc. devices

Submission Details

510(k) Number K963542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1996
Decision Date September 27, 1996
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 K963542.
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K963763 · Medica Corp. · Nov 1996
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K962334 · Radiometer America, Inc. · Oct 1996
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K963627 · Roche Diagnostic Systems, Inc. · Oct 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