Cleared Traditional

IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT (K083853) - FDA 510(k) Clearance

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

K083853 · Siemens Healthcare Diagnostics · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
90d
Days
Class 2
Risk

K083853 is an FDA 510(k) clearance for the IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on March 24, 2009 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - the FDA immunology 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 Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Siemens Healthcare Diagnostics devices

Submission Details

510(k) Number K083853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 2008
Decision Date March 24, 2009
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 104d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHB System, Test, Radioallergosorbent (rast) Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 Immunology devices follow this clearance model.

Regulatory Peers - DHB System, Test, Radioallergosorbent (rast) Immunological

All 105
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K083853.
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
K132801 · Siemens Healthcare Diagnostics, Inc. · May 2014
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K112523 · Siemens Healthcare Diagnostics, Inc. · Jan 2012
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
K093987 · Siemens Healthcare Diagnostics, Inc. · Mar 2011
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152 · Diagnostic Products Corp. · Dec 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206 · Diagnostic Products Corp. · May 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208 · Diagnostic Products Corp. · May 2002