Cleared Traditional

K112142 - DIMENSION VISTA LITHIUM FLEX REAGENT CA...

K112142 is an FDA 510(k) clearance for DIMENSION VISTA LITHIUM FLEX REAGENT CA..., manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Chemistry device with product code NDW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K112142 · Siemens Healthcare Diagnostics · Chemistry device
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Nov 2011
Decision
101d
Days
Class 2
Risk

K112142 is an FDA 510(k) clearance for the DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE. Classified as Assay, Porphyrin, Spectrophotometry, Lithium (product code NDW), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on November 4, 2011 after a review of 101 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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K112142

510(k) Number K112142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2011
Decision Date November 04, 2011
Days to Decision 101 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
13d slower than avg
Panel avg: 88d · This submission: 101d
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 K112142.
Diazyme Colorimetric Lithium Assay
K243462 · Diazyme Laboratories, Inc. · Aug 2025
COBAS LITHIUM
K063684 · Roche Diagnostics Corp. · Mar 2008
ADVIA IMS LITHIUM ASSAY
K050374 · Bayer Healthcare, LLC · Jun 2005
LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901
K003583 · Trace America, Inc. · Jan 2001