Cleared Traditional

K083314 - IMMULITE 2000 3GALLERGY SPECIFIC IGE AS...

K083314 is an FDA 510(k) clearance for IMMULITE 2000 3GALLERGY SPECIFIC IGE AS..., manufactured by Siemens Healthcare Diagnostics. The device is a Class 2 Immunology device with product code DHB cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K083314 · Siemens Healthcare Diagnostics · Immunology device
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Mar 2009
Decision
121d
Days
Class 2
Risk

K083314 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 11, 2009 after a review of 121 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

FDA 510(k) Submission Details - K083314

510(k) Number K083314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2008
Decision Date March 11, 2009
Days to Decision 121 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
17d slower than avg
Panel avg: 104d · This submission: 121d
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
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K083314.
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