Cleared Traditional

K871028 - CIBA CORNING MODEL 664/FAST 4 SYSTEM

K871028 is an FDA 510(k) clearance for CIBA CORNING MODEL 664/FAST 4 SYSTEM, 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 73-day FDA review.

K871028 · Ciba Corning Diagnostics Corp. · Chemistry device
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May 1987
Decision
73d
Days
Class 2
Risk

K871028 is an FDA 510(k) clearance for the CIBA CORNING MODEL 664/FAST 4 SYSTEM. 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 May 28, 1987 after a review of 73 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

FDA 510(k) Submission Details - K871028

510(k) Number K871028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1987
Decision Date May 28, 1987
Days to Decision 73 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
15d faster than avg
Panel avg: 88d · This submission: 73d
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 K871028.
SODIUM AND POTASSIUM BY ION SELECTIVE
K873074 · American Monitor Corp. · Oct 1987
CIBA CORNING MODEL 580 ALLIANCE I.S.E. MODULE
K872716 · Ciba Corning Diagnostics Corp. · Jul 1987
NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
K872190 · Nova Biomedical Corp. · Jun 1987
MEDICA EASYLYTE SODIUM/POTASSIUM ANALYZER
K864872 · Medica Corp. · Mar 1987
ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)
K863617 · Hi Chem, Inc. · Oct 1986
AVL MODEL 984 ELECTROLYTE ANALYZER
K862819 · Avl Scientific Corp. · Aug 1986