Cleared Traditional

K910052 - MILENIA BETA-2 MICROGLOBULIN

K910052 is the FDA 510(k) clearance for MILENIA BETA-2 MICROGLOBULIN by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code JZG) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K910052 · Diagnostic Products Corp. · Immunology device
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Mar 1991
Decision
58d
Days
Class 2
Risk

K910052 is an FDA 510(k) clearance for the MILENIA BETA-2 MICROGLOBULIN. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on March 6, 1991 after a review of 58 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K910052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 1991
Decision Date March 06, 1991
Days to Decision 58 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
46d faster than avg
Panel avg: 104d · This submission: 58d
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 39
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K910052.
DSL BETA 2 MICROGLOBULIN (DSL 6100)
K912173 · Diagnostic Systems Laboratories, Inc. · Aug 1991
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
K912940 · Diagnostic Products Corp. · Jul 1991
NA ALPHA 1 MICROGLOBULIN KIT
K904254 · Behring Diagnostics, Inc. · Apr 1991
PHARMACIA DELFIA SYSTEM B2-MICRO
K903578 · Pharmacia, Inc. · Aug 1990
PHARMACIA B2 MICRO EIA
K900449 · Pharmacia, Inc. · Feb 1990
BETA2 M-TRAC BY ENZYME BEAD-BASED IMMUNOASSAY EIA
K895496 · Incstar Corp. · Oct 1989