Cleared Traditional

K781024 - CERUOPLASMIN SERUM ANTI-HUMAN

K781024 is the FDA 510(k) clearance for CERUOPLASMIN SERUM ANTI-HUMAN by Icl Scientific. It is a Class 2 Immunology device (product code DDB) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K781024 · Icl Scientific · Immunology device
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Aug 1978
Decision
56d
Days
Class 2
Risk

K781024 is an FDA 510(k) clearance for the CERUOPLASMIN SERUM ANTI-HUMAN. Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5210 - 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.

View all Icl Scientific devices

Submission Details

510(k) Number K781024 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1978
Decision Date August 14, 1978
Days to Decision 56 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
48d faster than avg
Panel avg: 104d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDB Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5210
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 - DDB Ceruloplasmin, Antigen, Antiserum, Control

All 16
Devices cleared under the same product code (DDB) and FDA review panel - the closest regulatory comparables to K781024.
ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI
K790712 · Kent Laboratories, Inc. · Aug 1979
ANTISERUM TO HUMAN CERULOPLASMIN
K790714 · Kent Laboratories, Inc. · Aug 1979
HUMAN CERULOPLASMIN
K791339 · Beckman Instruments, Inc. · Aug 1979
CERULOPLASMIN NEPHEL. ASSAY
K772255 · Kallestad Laboratories, Inc. · Jan 1978
LAS-R CERULOPLASMIN TEST
K771795 · Hyland Therapeutic Div., Travenol Laboratories · Nov 1977