Cleared Special

K061730 - OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044

K061730 is an FDA 510(k) clearance for OSMETECH OPTI R CRITICAL CARE ANALYZER, manufactured by Osmetech, Inc.. The device is a Class 2 Chemistry device with product code CEM cleared through the Special 510(k) pathway after a 45-day FDA review.

K061730 · Osmetech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
45d
Days
Class 2
Risk

K061730 is an FDA 510(k) clearance for the OSMETECH OPTI R CRITICAL CARE ANALYZER, MODEL GD7044. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Osmetech, Inc. (Roswell, US). The FDA issued a Cleared decision on August 4, 2006 after a review of 45 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Osmetech, Inc. devices

FDA 510(k) Submission Details - K061730

510(k) Number K061730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2006
Decision Date August 04, 2006
Days to Decision 45 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Modification to existing cleared device.

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 66
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