Cleared Traditional

EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT (K060385) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K060385 · Dade Behring, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 2006
Decision
51d
Days
Class 2
Risk

K060385 is an FDA 510(k) clearance for the EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT. Classified as Enzyme Immunoassay, Tracrolimus (product code MLM), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on April 6, 2006 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1678 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dade Behring, Inc. devices

Submission Details

510(k) Number K060385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2006
Decision Date April 06, 2006
Days to Decision 51 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
37d faster than avg
Panel avg: 88d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - MLM Enzyme Immunoassay, Tracrolimus

All 8
Devices cleared under the same product code (MLM) and FDA review panel - the closest regulatory comparables to K060385.
Tacrolimus Assay Kit
K203833 · Shanghai Genext Medical Technology Co., Ltd. · Jan 2023
Elecsys Tacrolimus
K173857 · Roche Diagnostics · Nov 2018
Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL)
K150168 · Siemens Healthcare Diagnostics · Nov 2015
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
K060502 · Dade Behring, Inc. · May 2006