Cleared Traditional

K913131 - HUMAN BETA-2 MICROGLOBIN EN-RID KIT

K913131 is the FDA 510(k) clearance for HUMAN BETA-2 MICROGLOBIN EN-RID KIT by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code JZG) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K913131 · The Binding Site, Ltd. · Immunology device
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Nov 1991
Decision
114d
Days
Class 2
Risk

K913131 is an FDA 510(k) clearance for the HUMAN BETA-2 MICROGLOBIN EN-RID KIT. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on November 7, 1991 after a review of 114 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 The Binding Site, Ltd. devices

Submission Details

510(k) Number K913131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1991
Decision Date November 07, 1991
Days to Decision 114 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
10d slower than avg
Panel avg: 104d · This submission: 114d
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 K913131.
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
DSL BETA 2 MICROGLOBULIN (DSL 6200)
K911881 · Diagnostic Systems Laboratories, Inc. · Sep 1991
DSL BETA 2 MICROGLOBULIN (DSL 6100)
K912173 · Diagnostic Systems Laboratories, Inc. · Aug 1991
COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA
K912940 · Diagnostic Products Corp. · Jul 1991