Cleared Traditional

IMX B2-MICROGLOBULIN (K890421) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K890421 · Abbott Laboratories · Immunology device
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Mar 1989
Decision
42d
Days
Class 2
Risk

K890421 is an FDA 510(k) clearance for the IMX B2-MICROGLOBULIN. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 9, 1989 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5630 - 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 Abbott Laboratories devices

Submission Details

510(k) Number K890421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1989
Decision Date March 09, 1989
Days to Decision 42 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
62d faster than avg
Panel avg: 104d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JZG System, Test, Beta-2-microglobulin Immunological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5630
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 - JZG System, Test, Beta-2-microglobulin Immunological

All 29
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K890421.
MILENIA BETA-2 MICROGLOBULIN
K910052 · Diagnostic Products Corp. · Mar 1991
PHARMACIA DELFIA SYSTEM B2-MICRO
K903578 · Pharmacia, Inc. · Aug 1990
PHARMACIA B2 MICRO EIA
K900449 · Pharmacia, Inc. · Feb 1990
PHARMACIA B2-MICRO RIA
K880719 · Pharmacia, Inc. · Apr 1988
ABBOTT B2-MICROGLOBULIN RIA
K864130 · Abbott Laboratories · Nov 1986
PHARMACIA B2-MICRO EIA
K844469 · Pharmacia, Inc. · Feb 1985