Cleared Traditional

CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE (K872716) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K872716 · Ciba Corning Diagnostics Corp. · Chemistry device
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Jul 1987
Decision
21d
Days
Class 2
Risk

K872716 is an FDA 510(k) clearance for the CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE. Classified as Electrode, Ion Specific, Sodium (product code JGS), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (East Walpole, US). The FDA issued a Cleared decision on July 31, 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 Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K872716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1987
Decision Date July 31, 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 49
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K872716.
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672 · Technicon Instruments Corp. · Oct 1989
CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE
K892500 · Ciba Corning Diagnostics Corp. · Jul 1989
ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)
K875263 · Technicon Instruments Corp. · Feb 1988
CIBA CORNING MODEL 664/FAST 4 SYSTEM
K871028 · Ciba Corning Diagnostics Corp. · May 1987
ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704
K861696 · Boehringer Mannheim Corp. · Jul 1986
ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA
K852473 · Roche Diagnostic Systems, Inc. · Jul 1985