Cleared Traditional

MASSTRAK IMMUNOSUPPRESSANTS KIT (K063868) - FDA 510(k) Clearance

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

K063868 · Waters Corporation · Toxicology device
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May 2007
Decision
147d
Days
Class 2
Risk

K063868 is an FDA 510(k) clearance for the MASSTRAK IMMUNOSUPPRESSANTS KIT. Classified as Enzyme Immunoassay, Tracrolimus (product code MLM), Class II - Special Controls.

Submitted by Waters Corporation (Beverly, US). The FDA issued a Cleared decision on May 25, 2007 after a review of 147 days - within the typical 510(k) review window.

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 Waters Corporation devices

Submission Details

510(k) Number K063868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2006
Decision Date May 25, 2007
Days to Decision 147 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 87d · This submission: 147d
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 Toxicology 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 K063868.
Tacrolimus Assay Kit
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K150168 · Siemens Healthcare Diagnostics · Nov 2015
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