Cleared Traditional

K042411 - ABBOTT IMX SIROLIMUS MICROPARTICLE ENZY...

K042411 is the FDA 510(k) clearance for ABBOTT IMX SIROLIMUS MICROPARTICLE ENZY... by Axis-Shield , Ltd.. It is a Class 2 Toxicology device (product code NRP) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K042411 · Axis-Shield , Ltd. · Toxicology device
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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.

Regulatory Peers - NRP Sirolimus Test System

Devices cleared under the same product code (NRP) and FDA review panel - the closest regulatory comparables to K042411.
EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR
K083487 · Siemens Healthcare Diagnostics · Mar 2009
DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306
K081857 · Siemens Healthcare Diagnostics, Inc. · Oct 2008
ARCHITECT SIROLIMUS ASSAY
K070822 · Fujirebio Diagnostics,Inc. · Sep 2007
CEDIA SIROLIMUS ASSAY
DEN040008 · Microgenics Corp. · Jul 2004