Cleared Traditional

K112523 - IMMULITE 2000 3GALLERGY SPECIFIC IGE AS...

K112523 is the FDA 510(k) clearance for IMMULITE 2000 3GALLERGY SPECIFIC IGE AS... by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K112523 · Siemens Healthcare Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
128d
Days
Class 2
Risk

K112523 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, Inc. (Tarrytown, US). The FDA issued a Cleared decision on January 6, 2012 after a review of 128 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, Inc. devices

Submission Details

510(k) Number K112523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2011
Decision Date January 06, 2012
Days to Decision 128 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 104d · This submission: 128d
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 187
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K112523.
ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
K173726 · Phadia AB · Apr 2018
IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY
K132801 · Siemens Healthcare Diagnostics, Inc. · May 2014
IMMUNOCAP ALLERGEN K82
K121463 · Thermo Fisher Scientific · Jan 2013
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K101572 · Siemens Healthcare Diagnostics · Aug 2011
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
K093987 · Siemens Healthcare Diagnostics, Inc. · Mar 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K093107 · Siemens Healthcare Diagnostics · Sep 2010