Cleared Traditional

ARCHITECT TACROLIMUS: MODEL 1L77 (K070820) - FDA 510(k) Clearance

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

K070820 · Fujirebio Diagnostics,Inc. · Toxicology device
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Aug 2007
Decision
128d
Days
Class 2
Risk

K070820 is an FDA 510(k) clearance for the ARCHITECT TACROLIMUS: MODEL 1L77. Classified as Enzyme Immunoassay, Tracrolimus (product code MLM), Class II - Special Controls.

Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on August 1, 2007 after a review of 128 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 Fujirebio Diagnostics,Inc. devices

Submission Details

510(k) Number K070820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date August 01, 2007
Days to Decision 128 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
41d slower than avg
Panel avg: 87d · This submission: 128d
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 K070820.
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K060502 · Dade Behring, Inc. · May 2006
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K060385 · Dade Behring, Inc. · Apr 2006