Cleared Abbreviated

CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS (K080459) - FDA 510(k) Clearance

Class I Toxicology device.

K080459 · Chromsystems Instruments & Chemicals GmbH · Toxicology device
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Optimized for regulatory review, auditing and printing
Nov 2009
Decision
636d
Days
Class 1
Risk

K080459 is an FDA 510(k) clearance for the CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS. Classified as Drug Specific Control Materials (product code LAS), Class I - General Controls.

Submitted by Chromsystems Instruments & Chemicals GmbH (Marietta, US). The FDA issued a Cleared decision on November 17, 2009 after a review of 636 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3280 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Chromsystems Instruments & Chemicals GmbH devices

Submission Details

510(k) Number K080459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2008
Decision Date November 17, 2009
Days to Decision 636 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
549d slower than avg
Panel avg: 87d · This submission: 636d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LAS Drug Specific Control Materials
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3280
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LAS Drug Specific Control Materials

All 82
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