Cleared Traditional

K901333 - BETA-2 MICROGLOBULIN EIA

K901333 is an FDA 510(k) clearance for BETA-2 MICROGLOBULIN EIA, manufactured by Serex, Inc.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K901333 · Serex, Inc. · Immunology device
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Apr 1990
Decision
13d
Days
Class 2
Risk

K901333 is an FDA 510(k) clearance for the BETA-2 MICROGLOBULIN EIA. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Serex, Inc. (Tenafly, US). The FDA issued a Cleared decision on April 2, 1990 after a review of 13 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 Serex, Inc. devices

FDA 510(k) Submission Details - K901333

510(k) Number K901333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1990
Decision Date April 02, 1990
Days to Decision 13 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 105d · This submission: 13d
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 47
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K901333.
NA ALPHA 1 MICROGLOBULIN KIT
K904254 · Behring Diagnostics, Inc. · Apr 1991
MILENIA BETA-2 MICROGLOBULIN
K910052 · Diagnostic Products Corp. · Mar 1991
PHARMACIA DELFIA SYSTEM B2-MICRO
K903578 · Pharmacia, Inc. · Aug 1990
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