Cleared Traditional

K931806 - IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE

K931806 is an FDA 510(k) clearance for IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code CZP cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K931806 · The Binding Site, Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K931806

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 105d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZP Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K931806.
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
K955794 · Randox Laboratories, Ltd. · Apr 1996
BOEHRINGER MANNHEIM IGA ASSAY
K955907 · Boehringer Mannheim Corp. · Feb 1996
N LATEX IGA
K952309 · Behring Diagnostics, Inc. · Jun 1995
IL TEST IMMUNOGLOBULIN A
K920014 · Instrumentation Laboratory CO · Jun 1992
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
K900422 · Helena Laboratories · Feb 1990
RAICHEM(TM) SPIA(TM) IGA REAGENTS
K894418 · Reagents Applications, Inc. · Aug 1989