Cleared Traditional

IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE (K931806) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K931806 · The Binding Site, Ltd. · Immunology device
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Jul 1993
Decision
95d
Days
Class 2
Risk

K931806 is an FDA 510(k) clearance for the IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on July 16, 1993 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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 K931806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1993
Decision Date July 16, 1993
Days to Decision 95 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 104d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZP Iga, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CZP Iga, Antigen, Antiserum, Control

All 53
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K931806.
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
K193525 · HORIBA ABX SAS · Jun 2020
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
K060130 · Beckman Coulter, Inc. · Feb 2006
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · Roche Diagnostics Corp. · Mar 2004
N LATEX IGA
K024038 · Dade Behring, Inc. · Feb 2003
IGA
K983359 · Abbott Laboratories · Nov 1998
QUANTEX IGA
K962200 · Instrumentation Laboratory CO · Sep 1996