Cleared Traditional

K920132 - SYN ELISA BETA 2 MICROGLOBULIN TEST KIT

K920132 is an FDA 510(k) clearance for SYN ELISA BETA 2 MICROGLOBULIN TEST KIT, manufactured by Elias U.S.A., Inc.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K920132 · Elias U.S.A., Inc. · Immunology device
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May 1992
Decision
136d
Days
Class 2
Risk

K920132 is an FDA 510(k) clearance for the SYN ELISA BETA 2 MICROGLOBULIN TEST KIT. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on May 28, 1992 after a review of 136 days - within the typical 510(k) review window.

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 Elias U.S.A., Inc. devices

FDA 510(k) Submission Details - K920132

510(k) Number K920132 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1992
Decision Date May 28, 1992
Days to Decision 136 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
31d slower than avg
Panel avg: 105d · This submission: 136d
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 K920132.
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
COULTER BETA-2 MICROGLOBULIN IMMUNOASSAY
K923421 · Coulter Corp. · Sep 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
HUMAN BETA-2 MICROGLOBIN EN-RID KIT
K913131 · The Binding Site, Ltd. · Nov 1991