Cleared Traditional

K772080 - RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT

K772080 is an FDA 510(k) clearance for RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT, manufactured by Gelman Instrument Co.. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K772080 · Gelman Instrument Co. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1978
Decision
92d
Days
Class 2
Risk

K772080 is an FDA 510(k) clearance for the RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Gelman Instrument Co. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1978 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5130 - 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 Gelman Instrument Co. devices

FDA 510(k) Submission Details - K772080

510(k) Number K772080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1977
Decision Date February 03, 1978
Days to Decision 92 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 105d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DEM Device Classification - Class 2, Special Controls

Product Code DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5130
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 - DEM Alpha-1-antitrypsin, Antigen, Antiserum, Control

All 26
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K772080.
QM2/QM300 CONTROL B PACK
K875283 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1988
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
K801669 · J.T. Baker Chemical Co. · Sep 1980
RID SYSTEM-(ACP) TEST
K781408 · Icl Scientific · Aug 1978
LAS-R HUMAN ALPHA, ANTITRYPSIN TEST
K760916 · Hyland Therapeutic Div., Travenol Laboratories · Nov 1976
TEST, STREP, LATEX SLIDE
K760034 · Gamma Biologicals, Inc. · Aug 1976