Cleared Traditional

K923421 - COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY

K923421 is an FDA 510(k) clearance for COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY, manufactured by Coulter Corp.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K923421 · Coulter Corp. · Immunology device
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Sep 1992
Decision
72d
Days
Class 2
Risk

K923421 is an FDA 510(k) clearance for the COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on September 23, 1992 after a review of 72 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 Coulter Corp. devices

FDA 510(k) Submission Details - K923421

510(k) Number K923421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1992
Decision Date September 23, 1992
Days to Decision 72 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 105d · This submission: 72d
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 46
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K923421.
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · Beckman Instruments, Inc. · Apr 1994
IMMULITE BETA-2-MICROGLOBULIN
K931702 · Diagnostic Products Corp. · Sep 1993
ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK
K933648 · Dupont Medical Products · Sep 1993
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT
K920132 · Elias U.S.A., Inc. · May 1992
DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)
K915508 · Diagnostic Systems Laboratories, Inc. · Mar 1992
ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR
K914225 · E.I. Dupont DE Nemours & Co., Inc. · Nov 1991