Cleared Traditional

K842786 - DYNA-LYTE 2000

K842786 is the FDA 510(k) clearance for DYNA-LYTE 2000 by Abbott Diagnostics. It is a Class 2 Chemistry device (product code CEM) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K842786 · Abbott Diagnostics · Chemistry device
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Sep 1984
Decision
115d
Days
Class 2
Risk

K842786 is an FDA 510(k) clearance for the DYNA-LYTE 2000. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Abbott Diagnostics (Mountain View, US). The FDA issued a Cleared decision on September 14, 1984 after a review of 115 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.

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Submission Details

510(k) Number K842786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1984
Decision Date September 14, 1984
Days to Decision 115 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 88d · This submission: 115d
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 57
Devices cleared under the same product code (CEM) and FDA review panel - the closest regulatory comparables to K842786.
SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, &
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K844044 · Medica Corp. · Nov 1984
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K843239 · Coulter Electronics, Inc. · Oct 1984
ION SELECTIVE ELECTRODES & REAGENT SYS
K843008 · American Monitor Corp. · Sep 1984
AMRESCO E2A REAGENT SET 0562 & 0626
K840887 · American Research Products Co. · Apr 1984
ACID BASE LABORATORY ABL4
K833696 · Radiometer America, Inc. · Jan 1984