Cleared Traditional

K791605 - GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN

K791605 is an FDA 510(k) clearance for GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN, manufactured by Protos Laboratories. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K791605 · Protos Laboratories · Immunology device
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Sep 1979
Decision
15d
Days
Class 2
Risk

K791605 is an FDA 510(k) clearance for the GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by Protos Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979 after a review of 15 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K791605

510(k) Number K791605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1979
Decision Date September 04, 1979
Days to Decision 15 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
90d faster than avg
Panel avg: 105d · This submission: 15d
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 29
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K791605.
QM2/QM300 CONTROL B PACK
K875283 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1988
SPQ TEST SYSTEM FOR ALPHA, - ANTITRYPSIN
K850587 · Applications Lab · Mar 1985
J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO
K801669 · J.T. Baker Chemical Co. · Sep 1980
RID SYSTEM-(ACP) TEST
K781408 · Icl Scientific · Aug 1978
RADIAL IMMUNODIFFUSION KIT-ALPH-L-ANTIT
K772080 · Gelman Instrument Co. · Feb 1978
LAS-R HUMAN ALPHA, ANTITRYPSIN TEST
K760916 · Hyland Therapeutic Div., Travenol Laboratories · Nov 1976
K791605 · GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSIN
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