Cleared Traditional

K063705 - LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL

K063705 is an FDA 510(k) clearance for LITHIUM MICRO VOLUME ELECTRODE, manufactured by Thermo Electron OY. The device is a Class 2 Toxicology device with product code NDW cleared through the Traditional 510(k) pathway after a 300-day FDA review.

K063705 · Thermo Electron OY · Toxicology device
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Optimized for regulatory review, auditing and printing
Oct 2007
Decision
300d
Days
Class 2
Risk

K063705 is an FDA 510(k) clearance for the LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM.... Classified as Assay, Porphyrin, Spectrophotometry, Lithium (product code NDW), Class II - Special Controls.

Submitted by Thermo Electron OY (Vantaa, FI). The FDA issued a Cleared decision on October 9, 2007 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3560 - the FDA toxicology device 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermo Electron OY devices

FDA 510(k) Submission Details - K063705

510(k) Number K063705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2006
Decision Date October 09, 2007
Days to Decision 300 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 87d · This submission: 300d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDW Device Classification - Class 2, Special Controls

Product Code NDW Assay, Porphyrin, Spectrophotometry, 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.

Regulatory Peers - NDW Assay, Porphyrin, Spectrophotometry, Lithium

Devices cleared under the same product code (NDW) and FDA review panel - the closest regulatory comparables to K063705.
Diazyme Colorimetric Lithium Assay
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K050374 · Bayer Healthcare, LLC · Jun 2005
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K003583 · Trace America, Inc. · Jan 2001