Cleared Traditional

K061412 - THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401

K061412 is an FDA 510(k) clearance for THERMO ELECTRON ENZYMATIC CREATININE, manufactured by Thermo-Electron Corp.. The device is a Class 2 Chemistry device with product code JFY cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K061412 · Thermo-Electron Corp. · Chemistry device
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Mar 2007
Decision
305d
Days
Class 2
Risk

K061412 is an FDA 510(k) clearance for the THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401. Classified as Enzymatic Method, Creatinine (product code JFY), Class II - Special Controls.

Submitted by Thermo-Electron Corp. (Pittsburg, US). The FDA issued a Cleared decision on March 23, 2007 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1225 - 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. Elevated predicate reliance profile. 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 Corp. devices

FDA 510(k) Submission Details - K061412

510(k) Number K061412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 2006
Decision Date March 23, 2007
Days to Decision 305 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
217d slower than avg
Panel avg: 88d · This submission: 305d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JFY Device Classification - Class 2, Special Controls

Product Code JFY Enzymatic Method, Creatinine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1225
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 - JFY Enzymatic Method, Creatinine

All 39
Devices cleared under the same product code (JFY) and FDA review panel - the closest regulatory comparables to K061412.
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K071216 · Ortho-Clinical Diagnostics, Inc. · May 2007
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K063591 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
POLY-CHEM CREATININE
K061944 · Polymedco, Inc. · Nov 2006