Cleared Traditional

K790479 - A-GENT IMMUNOGLOBULINE TEST SYSTEM

K790479 is an FDA 510(k) clearance for A-GENT IMMUNOGLOBULINE TEST SYSTEM, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CZP cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K790479 · Abbott Laboratories · Chemistry device
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Apr 1979
Decision
26d
Days
Class 2
Risk

K790479 is an FDA 510(k) clearance for the A-GENT IMMUNOGLOBULINE TEST SYSTEM. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 3, 1979 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5510 - the FDA in vitro diagnostics and chemistry 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K790479

510(k) Number K790479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1979
Decision Date April 03, 1979
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZP Device Classification - Class 2, Special Controls

Product Code CZP Iga, 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 Chemistry devices follow this clearance model.

Regulatory Peers - CZP Iga, Antigen, Antiserum, Control

All 44
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K790479.
IMMUNOGLOBULIN A REAGENT SYSTEM
K800211 · Calbiochem-Behring Corp. · Feb 1980
LANCER L-INA ANTI-IGA
K791401 · Sherwood Medical Co. · Oct 1979
ANTISERUM, HUMAN, IGA
K790703 · Kent Laboratories, Inc. · Apr 1979
IMMUNOGLOBULIN A NEPHEL. ASSAY
K772251 · Kallestad Laboratories, Inc. · Dec 1977
IMMOCHEMISTRY SYSTEM
K771603 · Beckman Instruments, Inc. · Sep 1977
GOAT ANTISERUM IGA NEPHELOMETRIC
K770962 · Kallestad Laboratories, Inc. · Jun 1977