Cleared Traditional

K801669 - J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO

K801669 is an FDA 510(k) clearance for J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO, manufactured by J.T. Baker Chemical Co.. The device is a Class 2 Immunology device with product code DEM cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K801669 · J.T. Baker Chemical Co. · Immunology device
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Sep 1980
Decision
56d
Days
Class 2
Risk

K801669 is an FDA 510(k) clearance for the J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO. Classified as Alpha-1-antitrypsin, Antigen, Antiserum, Control (product code DEM), Class II - Special Controls.

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on September 16, 1980 after a review of 56 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.

View all J.T. Baker Chemical Co. devices

FDA 510(k) Submission Details - K801669

510(k) Number K801669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1980
Decision Date September 16, 1980
Days to Decision 56 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
49d faster than avg
Panel avg: 105d · This submission: 56d
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 25
Devices cleared under the same product code (DEM) and FDA review panel - the closest regulatory comparables to K801669.
ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM
K882446 · Technicon Instruments Corp. · Jul 1988
QM300 ALPHA1-ANTITRYPSIN ANTIBODY PACK
K875281 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1988
QM2/QM300 CONTROL B PACK
K875283 · Kallestad Diag, A Div. of Erbamont, Inc. · Feb 1988
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