Cleared Traditional

K853068 - ILEX PROMPT CLINICAL CHEMISTRY ANALYER

K853068 is an FDA 510(k) clearance for ILEX PROMPT CLINICAL CHEMISTRY ANALYER, manufactured by Ilex Corp.. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K853068 · Ilex Corp. · Chemistry device
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Oct 1985
Decision
101d
Days
Class 2
Risk

K853068 is an FDA 510(k) clearance for the ILEX PROMPT CLINICAL CHEMISTRY ANALYER. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Ilex Corp. (Attleboro, US). The FDA issued a Cleared decision on October 31, 1985 after a review of 101 days - within the typical 510(k) review window.

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: 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 Ilex Corp. devices

FDA 510(k) Submission Details - K853068

510(k) Number K853068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1985
Decision Date October 31, 1985
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CEM Device Classification - Class 2, Special Controls

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 71
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K853068.
AMRESCO FLOW PAC POTASSIUM REAGENT SET, #1460
K870033 · American Research Products Co. · Jan 1987
SKD ELECTROCHEMICAL SYSTEM (ECS)
K854723 · Smithkline Diagnostics, Inc. · Mar 1986
IRON
K854298 · Boehringer Mannheim Corp. · Nov 1985
ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER
K853531 · American Dade · Sep 1985
VISION POTASSIUM
K850950 · Abbott Laboratories · Aug 1985
ION 2 REAGENT KI
K851350 · Hi Chem, Inc. · Apr 1985