Cleared Traditional

ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK (K933648) - FDA 510(k) Clearance

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

K933648 · Dupont Medical Products · Immunology device
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Sep 1993
Decision
59d
Days
Class 2
Risk

K933648 is an FDA 510(k) clearance for the ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on September 24, 1993 after a review of 59 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 Dupont Medical Products devices

Submission Details

510(k) Number K933648 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1993
Decision Date September 24, 1993
Days to Decision 59 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 104d · This submission: 59d
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 18
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K933648.
IL TEST BETA-2MICROGLOBULIN
K943686 · Instrumentation Laboratory CO · May 1995
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · Beckman Instruments, Inc. · Apr 1994
IMMULITE BETA-2-MICROGLOBULIN
K931702 · Diagnostic Products Corp. · Sep 1993
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR
K914225 · E.I. Dupont DE Nemours & Co., Inc. · Nov 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