Cleared Traditional

K173857 - Elecsys Tacrolimus

K173857 is an FDA 510(k) clearance for Elecsys Tacrolimus, manufactured by Roche Diagnostics. The device is a Class 2 Toxicology device with product code MLM cleared through the Traditional 510(k) pathway after a 321-day FDA review.

K173857 · Roche Diagnostics · Toxicology device
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Nov 2018
Decision
321d
Days
Class 2
Risk

K173857 is an FDA 510(k) clearance for the Elecsys Tacrolimus. Classified as Enzyme Immunoassay, Tracrolimus (product code MLM), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on November 6, 2018 after a review of 321 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Roche Diagnostics devices

FDA 510(k) Submission Details - K173857

510(k) Number K173857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2017
Decision Date November 06, 2018
Days to Decision 321 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
234d slower than avg
Panel avg: 87d · This submission: 321d
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 K173857.
Tacrolimus Assay Kit
K203833 · Shanghai Genext Medical Technology Co., Ltd. · Jan 2023
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
K150168 · Siemens Healthcare Diagnostics · Nov 2015
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
K123343 · Microgenics Corp. · Jul 2013
ARCHITECT TACROLIMUS: MODEL 1L77
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