Cleared Traditional

CIBA CORNING MODEL 570 ALLIANCE I.S.E. MODULE (K892500) - FDA 510(k) Clearance

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

K892500 · Ciba Corning Diagnostics Corp. · Chemistry device
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Jul 1989
Decision
98d
Days
Class 2
Risk

K892500 is an FDA 510(k) clearance for the CIBA CORNING MODEL 570 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 20, 1989 after a review of 98 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 Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K892500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 1989
Decision Date July 20, 1989
Days to Decision 98 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
10d slower than avg
Panel avg: 88d · This submission: 98d
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 K892500.
ABBOTT VISION LYTE (TM) SODIUM
K903188 · Abbott Laboratories · Sep 1990
LYTENING(TM) 5, LYTENING(TM) SYSTEM 30
K896526 · Baxter Healthcare Corp · Jan 1990
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672 · Technicon Instruments Corp. · Oct 1989
ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R)
K875263 · Technicon Instruments Corp. · Feb 1988
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE
K872716 · Ciba Corning Diagnostics Corp. · Jul 1987
CIBA CORNING MODEL 664/FAST 4 SYSTEM
K871028 · Ciba Corning Diagnostics Corp. · May 1987