Cleared Traditional

K042411 - ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (FDA 510(k) Clearance)

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

K042411 · Axis-Shield , Ltd. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
212d
Days
Class 2
Risk

K042411 is an FDA 510(k) clearance for the ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY. Classified as Sirolimus Test System (product code NRP), Class II - Special Controls.

Submitted by Axis-Shield , Ltd. (Dundee, GB). The FDA issued a Cleared decision on April 7, 2005 after a review of 212 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3840 - 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 Axis-Shield , Ltd. devices

Submission Details

510(k) Number K042411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2004
Decision Date April 07, 2005
Days to Decision 212 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
125d slower than avg
Panel avg: 87d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NRP Sirolimus Test System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3840
Definition Sirolimus Test Systems Are Intended For The Quantitative Measurement Of Sirolimus In Whole Blood As An Aid In Management Of Transplant Patients Taking This Sirolimus.
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.