Cleared Traditional

K791339 - HUMAN CERULOPLASMIN

K791339 is an FDA 510(k) clearance for HUMAN CERULOPLASMIN, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DDB cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K791339 · Beckman Instruments, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1979
Decision
31d
Days
Class 2
Risk

K791339 is an FDA 510(k) clearance for the HUMAN CERULOPLASMIN. Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979 after a review of 31 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K791339

510(k) Number K791339 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1979
Decision Date August 16, 1979
Days to Decision 31 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
73d faster than avg
Panel avg: 104d · This submission: 31d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DDB Device Classification - Class 2, Special Controls

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 K791339.
J.T. BAKER CERULOPLASMIN NEPHELOMETRIC
K801661 · J.T. Baker Chemical Co. · Sep 1980
ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI
K790712 · Kent Laboratories, Inc. · Aug 1979
ANTISERUM TO HUMAN CERULOPLASMIN
K790714 · Kent Laboratories, Inc. · Aug 1979
CERUOPLASMIN SERUM ANTI-HUMAN
K781024 · Icl Scientific · Aug 1978
CERULOPLASMIN NEPHEL. ASSAY
K772255 · Kallestad Laboratories, Inc. · Jan 1978
LAS-R CERULOPLASMIN TEST
K771795 · Hyland Therapeutic Div., Travenol Laboratories · Nov 1977