Cleared Special

K082001 - DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K082001 · Diazyme Laboratories · Toxicology device
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Dec 2008
Decision
144d
Days
Class 2
Risk

K082001 is an FDA 510(k) clearance for the DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B. Classified as Atomic Absorption, Lithium (product code JII), Class II - Special Controls.

Submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on December 5, 2008 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3560 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

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Submission Details

510(k) Number K082001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2008
Decision Date December 05, 2008
Days to Decision 144 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 87d · This submission: 144d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JII Atomic Absorption, Lithium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3560
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 Toxicology devices follow this clearance model.