Cleared Traditional

K121463 - IMMUNOCAP ALLERGEN K82

K121463 is the FDA 510(k) clearance for IMMUNOCAP ALLERGEN K82 by Thermo Fisher Scientific. It is a Class 2 Immunology device (product code DHB) cleared through the Traditional 510(k) pathway after a 257-day FDA review.

K121463 · Thermo Fisher Scientific · Immunology device
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Jan 2013
Decision
257d
Days
Class 2
Risk

K121463 is an FDA 510(k) clearance for the IMMUNOCAP ALLERGEN K82. Classified as System, Test, Radioallergosorbent (rast) Immunological (product code DHB), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Portage, US). The FDA issued a Cleared decision on January 29, 2013 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 Thermo Fisher Scientific devices

Submission Details

510(k) Number K121463 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2012
Decision Date January 29, 2013
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.

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
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