Cleared Traditional

K061107 - DPC T60I KUSTI, MODEL 984248

Also marketed or referenced as:
DPC T60I, MODEL 984247

K061107 is an FDA 510(k) clearance for DPC T60I KUSTI, manufactured by Thermo Electron OY. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K061107 · Thermo Electron OY · Chemistry device
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Aug 2006
Decision
110d
Days
Class 2
Risk

K061107 is an FDA 510(k) clearance for the DPC T60I KUSTI, MODEL 984248. Classified as Electrode, Ion Specific, Potassium (product code CEM), Class II - Special Controls.

Submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on August 8, 2006 after a review of 110 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 Thermo Electron OY devices

FDA 510(k) Submission Details - K061107

510(k) Number K061107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2006
Decision Date August 08, 2006
Days to Decision 110 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 88d · This submission: 110d
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 69
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