Cleared Traditional

K150168 - Dimension Tacrolimus Flex Reagent Cartr...

K150168 is an FDA 510(k) clearance for Dimension Tacrolimus Flex Reagent Cartr..., manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Toxicology device with product code MLM cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K150168 · Siemens Healthcare Diagnostics · Toxicology device
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Nov 2015
Decision
282d
Days
Class 2
Risk

K150168 is an FDA 510(k) clearance for the Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Cali.... Classified as Enzyme Immunoassay, Tracrolimus (product code MLM), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on November 4, 2015 after a review of 282 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1678 - 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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K150168

510(k) Number K150168 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2015
Decision Date November 04, 2015
Days to Decision 282 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
195d slower than avg
Panel avg: 87d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLM Device Classification - Class 2, Special Controls

Product Code MLM Enzyme Immunoassay, Tracrolimus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1678
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 - MLM Enzyme Immunoassay, Tracrolimus

All 7
Devices cleared under the same product code (MLM) and FDA review panel - the closest regulatory comparables to K150168.
Tacrolimus Assay Kit
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THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343 · Microgenics Corp. · Jul 2013
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K070820 · Fujirebio Diagnostics,Inc. · Aug 2007
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
K060502 · Dade Behring, Inc. · May 2006
EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT
K060385 · Dade Behring, Inc. · Apr 2006