Cleared Traditional

K132801 - IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFI...

K132801 is an FDA 510(k) clearance for IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFI..., manufactured by Siemens Healthcare Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K132801 · Siemens Healthcare Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
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May 2014
Decision
257d
Days
Class 2
Risk

K132801 is an FDA 510(k) clearance for the IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY. 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 May 28, 2014 after a review of 257 days - an extended review cycle.

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

FDA 510(k) Submission Details - K132801

510(k) Number K132801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2013
Decision Date May 28, 2014
Days to Decision 257 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
153d slower than avg
Panel avg: 104d · This submission: 257d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHB Device Classification - Class 2, Special Controls

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 218
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