Cleared Traditional

K811124 - AIM SYSTEM (FOR IGM)

K811124 is the FDA 510(k) clearance for AIM SYSTEM (FOR IGM) by Icl Scientific. It is a Class 2 Immunology device (product code DFT) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K811124 · Icl Scientific · Immunology device
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May 1981
Decision
14d
Days
Class 2
Risk

K811124 is an FDA 510(k) clearance for the AIM SYSTEM (FOR IGM). Classified as Igm, Antigen, Antiserum, Control (product code DFT), Class II - Special Controls.

Submitted by Icl Scientific (Mchenry, US). The FDA issued a Cleared decision on May 8, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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 Icl Scientific devices

Submission Details

510(k) Number K811124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1981
Decision Date May 08, 1981
Days to Decision 14 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: 104d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFT Igm, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFT Igm, Antigen, Antiserum, Control

All 22
Devices cleared under the same product code (DFT) and FDA review panel - the closest regulatory comparables to K811124.
OPTIMATE IGM TEST
K841814 · Miles Laboratories, Inc. · Jun 1984
QUIK-SEP IGM ISOLATION SYSTEM
K830606 · Isolab, Inc. · Mar 1983
ACA IMMUNOGLOBIN M TEST PACK
K812632 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1981
AIP SYSTEM-METHOD FOR IGM
K803251 · Icl Scientific · Jan 1981
J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA
K801282 · J.T. Baker Chemical Co. · Jun 1980
IMMUNOGLOBULIN M REAGENT SYSTEM
K800167 · Calbiochem-Behring Corp. · Feb 1980