Cleared Traditional

K123343 - THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS

K123343 is an FDA 510(k) clearance for THERMO SCIENTIFIC QMS TACROLIMUS ASSAY ..., manufactured by Microgenics Corp.. The device is a Class 2 Toxicology device with product code MLM cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K123343 · Microgenics Corp. · Toxicology device
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Jul 2013
Decision
253d
Days
Class 2
Risk

K123343 is an FDA 510(k) clearance for the THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS. Classified as Enzyme Immunoassay, Tracrolimus (product code MLM), Class II - Special Controls.

Submitted by Microgenics Corp. (Fremont Blvd., US). The FDA issued a Cleared decision on July 11, 2013 after a review of 253 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 Microgenics Corp. devices

FDA 510(k) Submission Details - K123343

510(k) Number K123343 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2012
Decision Date July 11, 2013
Days to Decision 253 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
166d slower than avg
Panel avg: 87d · This submission: 253d
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 K123343.
Tacrolimus Assay Kit
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