Cleared Traditional

K070987 - SENTINEL LITHIUM ASSAY (FDA 510(k) Clearance)

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K070987 · SENTINEL CH. SpA · Toxicology device
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Aug 2007
Decision
118d
Days
Class 2
Risk

K070987 is an FDA 510(k) clearance for the SENTINEL LITHIUM ASSAY. Classified as Assay, Porphyrin, Spectrophotometry, Lithium (product code NDW), Class II - Special Controls.

Submitted by SENTINEL CH. SpA (Milan, IT). The FDA issued a Cleared decision on August 2, 2007 after a review of 118 days - within the typical 510(k) review window.

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 SENTINEL CH. SpA devices

Submission Details

510(k) Number K070987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date August 02, 2007
Days to Decision 118 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 87d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.