Cleared Traditional

K920132 - SYN ELISA BETA 2 MICROGLOBULIN TEST KIT

K920132 is the FDA 510(k) clearance for SYN ELISA BETA 2 MICROGLOBULIN TEST KIT by Elias U.S.A., Inc.. It is a Class 2 Immunology device (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

Submission Details

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
32d slower than avg
Panel avg: 104d · This submission: 136d
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 41
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K920132.
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · Beckman Instruments, Inc. · Apr 1994
IMMULITE BETA-2-MICROGLOBULIN
K931702 · Diagnostic Products Corp. · 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