Cleared Traditional

K890421 - IMX B2-MICROGLOBULIN

K890421 is an FDA 510(k) clearance for IMX B2-MICROGLOBULIN, manufactured by Abbott Laboratories. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K890421 · Abbott Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K890421

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.

JZG Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K890421.
AIA-PACK BMG
K900440 · Tosoh Medics, Inc. · Feb 1990
PHARMACIA B2 MICRO EIA
K900449 · Pharmacia, Inc. · Feb 1990
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA
K895496 · Incstar Corp. · Oct 1989
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