Cleared Traditional

K892500 - CIBA CORNING MODEL 570 ALLIANCE I.S.E. ...

K892500 is an FDA 510(k) clearance for CIBA CORNING MODEL 570 ALLIANCE I.S.E. ..., manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code JGS cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K892500 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K892500

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.

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 122
Devices cleared under the same product code (JGS) and FDA review panel - the closest regulatory comparables to K892500.
EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
K895936 · Medica Corp. · Dec 1989
TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD
K895672 · Technicon Instruments Corp. · Oct 1989
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
K894218 · Nova Biomedical Corp. · Sep 1989
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
K880750 · Nova Biomedical Corp. · Jul 1988
NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
K881255 · Nova Biomedical Corp. · May 1988
NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL
K874832 · Nova Biomedical Corp. · Feb 1988