Cleared Traditional

K121463 - IMMUNOCAP ALLERGEN K82

K121463 is an FDA 510(k) clearance for IMMUNOCAP ALLERGEN K82, manufactured by Thermo Fisher Scientific. 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.

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

FDA 510(k) Submission Details - K121463

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
152d slower than avg
Panel avg: 105d · 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 231
Devices cleared under the same product code (DHB) and FDA review panel - the closest regulatory comparables to K121463.
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K121156 · Phadia AB · Mar 2013
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K112910 · Hitachi Chemical Diagnostics, Inc. · Dec 2012
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K112523 · Siemens Healthcare Diagnostics, Inc. · Jan 2012