Cleared Traditional

K800211 - IMMUNOGLOBULIN A REAGENT SYSTEM

K800211 is the FDA 510(k) clearance for IMMUNOGLOBULIN A REAGENT SYSTEM by Calbiochem-Behring Corp.. It is a Class 2 Immunology device (product code CZP) cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K800211 · Calbiochem-Behring Corp. · Immunology device
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Feb 1980
Decision
18d
Days
Class 2
Risk

K800211 is an FDA 510(k) clearance for the IMMUNOGLOBULIN A REAGENT SYSTEM. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on February 19, 1980 after a review of 18 days - a notably fast clearance cycle.

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: 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 Calbiochem-Behring Corp. devices

Submission Details

510(k) Number K800211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1980
Decision Date February 19, 1980
Days to Decision 18 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
86d faster than avg
Panel avg: 104d · This submission: 18d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Immunology devices follow this clearance model.

Regulatory Peers - CZP Iga, Antigen, Antiserum, Control

All 42
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K800211.
AUTOMATED IMMUNOPRECIPITIN METHOD/IGA
K803274 · Icl Scientific · Jan 1981
J.T. BAKER IMMUNO. A NEPHELOMETRIC ASSAY
K801283 · J.T. Baker Chemical Co. · Jun 1980
GEMENI IGA ASSAY
K800449 · Electro-Nucleonics Laboratories, Inc. · Mar 1980
LANCER L-INA ANTI-IGA
K791401 · Sherwood Medical Co. · Oct 1979
ANTISERUM, HUMAN, IGA
K790703 · Kent Laboratories, Inc. · Apr 1979
A-GENT IMMUNOGLOBULINE TEST SYSTEM
K790479 · Abbott Laboratories · Apr 1979