Cleared Traditional

K083487 - EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR

K083487 is an FDA 510(k) clearance for EMIT 2000 SIROLIMUS ASSAY, manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Toxicology device with product code NRP cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K083487 · Siemens Healthcare Diagnostics · Toxicology device
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Mar 2009
Decision
125d
Days
Class 2
Risk

K083487 is an FDA 510(k) clearance for the EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, .... Classified as Sirolimus Test System (product code NRP), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on March 30, 2009 after a review of 125 days - within the typical 510(k) review window.

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 Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K083487

510(k) Number K083487 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2008
Decision Date March 30, 2009
Days to Decision 125 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 87d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NRP Device Classification - Class 2, Special Controls

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 K083487.
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
ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY
K042411 · Axis-Shield , Ltd. · Apr 2005
CEDIA SIROLIMUS ASSAY
DEN040008 · Microgenics Corp. · Jul 2004