Cleared Traditional

K895664 - TECHNICON DAX SYSTEM - POTASSIUM (ISE) ...

K895664 is the FDA 510(k) clearance for TECHNICON DAX SYSTEM - POTASSIUM (ISE) ... by Technicon Instruments Corp.. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K895664 · Technicon Instruments Corp. · Chemistry device
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Nov 1989
Decision
55d
Days
Class 2
Risk

K895664 is an FDA 510(k) clearance for the TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Technicon Instruments Corp. (Tarrytown, US). The FDA issued a Cleared decision on November 14, 1989 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1600 - 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 Technicon Instruments Corp. devices

Submission Details

510(k) Number K895664 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date November 14, 1989
Days to Decision 55 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
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEM Electrode, Ion Specific, Potassium

All 52
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K895664.
IONOMETER EH-HK AND ACCESSORIES
K901041 · Fresenius USA, Inc. · Jun 1990
LYTENING 2Z LYTENING SYSTEM 31
K900300 · Baxter Healthcare Corp · Mar 1990
AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER
K896692 · Baxter Healthcare Corp · Jan 1990
MODEL 654 A SODIUM, POTASSIUM & LITHIUM ISE ANALY
K884769 · Ciba Corning Diagnostics Corp. · Jan 1989
VISION LYTE (TM) POTASSIUM
K884566 · Abbott Laboratories · Dec 1988
AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460
K870033 · American Research Products Co. · Jan 1987