Cleared Traditional

K791285 - ANTI-HUMAN GLOBULINS

K791285 is the FDA 510(k) clearance for ANTI-HUMAN GLOBULINS by Diagnostica, Inc.. It is a Class 2 Immunology device (product code DEW) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K791285 · Diagnostica, Inc. · Immunology device
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Oct 1979
Decision
99d
Days
Class 2
Risk

K791285 is an FDA 510(k) clearance for the ANTI-HUMAN GLOBULINS. Classified as Igg, Antigen, Antiserum, Control (product code DEW), Class II - Special Controls.

Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 99 days - within the typical 510(k) review window.

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: 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 Diagnostica, Inc. devices

Submission Details

510(k) Number K791285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1979
Decision Date October 17, 1979
Days to Decision 99 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 104d · This submission: 99d
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 55
Devices cleared under the same product code (DEW) and FDA review panel - the closest regulatory comparables to K791285.
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC.
K800897 · Icl Scientific · May 1980
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 TO HUMAN IMMUNOGLOBULINS
K791824 · Icl Scientific · Oct 1979
ANTISERUM, HUMAN, IGG H & L CHAIN
K790702 · Kent Laboratories, Inc. · Sep 1979