Cleared Traditional

K931702 - IMMULITE BETA-2-MICROGLOBULIN

K931702 is an FDA 510(k) clearance for IMMULITE BETA-2-MICROGLOBULIN, manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K931702 · Diagnostic Products Corp. · Immunology device
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Sep 1993
Decision
171d
Days
Class 2
Risk

K931702 is an FDA 510(k) clearance for the IMMULITE 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 September 24, 1993 after a review of 171 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K931702

510(k) Number K931702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1993
Decision Date September 24, 1993
Days to Decision 171 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 105d · This submission: 171d
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 45
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K931702.
IL TEST BETA-2MICROGLOBULIN
K943686 · Instrumentation Laboratory CO · May 1995
LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2
K946048 · Clinical Controls, Inc. · Feb 1995
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · Beckman Instruments, Inc. · Apr 1994
ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK
K933648 · Dupont Medical Products · Sep 1993
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
K923421 · Coulter Corp. · Sep 1992
SYN ELISA BETA 2 MICROGLOBULIN TEST KIT
K920132 · Elias U.S.A., Inc. · May 1992