Cleared Traditional

K791824 - ANTISERUM TO HUMAN IMMUNOGLOBULINS

K791824 is the FDA 510(k) clearance for ANTISERUM TO HUMAN IMMUNOGLOBULINS by Icl Scientific. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K791824 · Icl Scientific · Immunology device
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Oct 1979
Decision
33d
Days
Class 2
Risk

K791824 is an FDA 510(k) clearance for the ANTISERUM TO HUMAN IMMUNOGLOBULINS. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 K791824 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1979
Decision Date October 17, 1979
Days to Decision 33 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
71d faster than avg
Panel avg: 104d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEW Igg, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - DEW Igg, Antigen, Antiserum, Control

All 54
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K791824.
GEMENI IGG ASSAY
K800451 · Electro-Nucleonics Laboratories, Inc. · Apr 1980
IMMUNOGLOBULIN G REAGENT SYSTEM
K800119 · Calbiochem-Behring Corp. · Feb 1980
LANCER L-INA ANTI-IGG
K791403 · Sherwood Medical Co. · Oct 1979
ANTISERUM, HUMAN, IGG H & L CHAIN
K790702 · Kent Laboratories, Inc. · Sep 1979
ANTISERUM TO HUMAN IGG
K790704 · Kent Laboratories, Inc. · Apr 1979
IMMUNOGLOBULIN G NEPHEL. ASSAY
K772252 · Kallestad Laboratories, Inc. · Dec 1977