Cleared Traditional

K781028 - KAPPA SERUM (FREE & BOUND) ANTI-HUMAN

K781028 is the FDA 510(k) clearance for KAPPA SERUM (FREE & BOUND) ANTI-HUMAN by Icl Scientific. It is a Class 2 Immunology device (product code DFH) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K781028 · Icl Scientific · Immunology device
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Jul 1978
Decision
38d
Days
Class 2
Risk

K781028 is an FDA 510(k) clearance for the KAPPA SERUM (FREE & BOUND) ANTI-HUMAN. Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on July 27, 1978 after a review of 38 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K781028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1978
Decision Date July 27, 1978
Days to Decision 38 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 104d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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.