Cleared Traditional

K050374 - ADVIA IMS LITHIUM ASSAY

K050374 is an FDA 510(k) clearance for ADVIA IMS LITHIUM ASSAY, manufactured by Bayer Healthcare, LLC. The device is a Class 2 Chemistry device with product code NDW cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K050374 · Bayer Healthcare, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
121d
Days
Class 2
Risk

K050374 is an FDA 510(k) clearance for the ADVIA IMS LITHIUM ASSAY. Classified as Assay, Porphyrin, Spectrophotometry, Lithium (product code NDW), Class II - Special Controls.

Submitted by Bayer Healthcare, LLC (Tarrytown, US). The FDA issued a Cleared decision on June 15, 2005 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3560 - 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 Bayer Healthcare, LLC devices

FDA 510(k) Submission Details - K050374

510(k) Number K050374 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2005
Decision Date June 15, 2005
Days to Decision 121 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 88d · This submission: 121d
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 Chemistry 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 K050374.
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
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
K003583 · Trace America, Inc. · Jan 2001