Cleared Traditional

K070987 - SENTINEL LITHIUM ASSAY

K070987 is an FDA 510(k) clearance for SENTINEL LITHIUM ASSAY, manufactured by SENTINEL CH. SpA. The device is a Class 2 Toxicology device with product code NDW cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K070987 · SENTINEL CH. SpA · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K070987

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.

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 K070987.
Diazyme Colorimetric Lithium Assay
K243462 · Diazyme Laboratories, Inc. · Aug 2025
DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE
K112142 · Siemens Healthcare Diagnostics · Nov 2011
COBAS LITHIUM
K063684 · Roche Diagnostics Corp. · Mar 2008
ADVIA IMS LITHIUM ASSAY
K050374 · Bayer Healthcare, LLC · Jun 2005