Cleared Traditional

K943686 - IL TEST BETA-2MICROGLOBULIN

K943686 is an FDA 510(k) clearance for IL TEST BETA-2MICROGLOBULIN, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 290-day FDA review.

K943686 · Instrumentation Laboratory CO · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
290d
Days
Class 2
Risk

K943686 is an FDA 510(k) clearance for the IL TEST BETA-2MICROGLOBULIN. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on May 15, 1995 after a review of 290 days - an extended review cycle.

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 Instrumentation Laboratory CO devices

FDA 510(k) Submission Details - K943686

510(k) Number K943686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1994
Decision Date May 15, 1995
Days to Decision 290 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
185d slower than avg
Panel avg: 105d · This submission: 290d
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 45
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K943686.
HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT
K946069 · The Binding Site, Ltd. · Jan 1996
HUMAN BETA-2 MICROGLOBULIN TURBINDIMETRIC KIT
K946070 · The Binding Site, Ltd. · Jan 1996
AURAFLEX B2-MICROGLOBULIN
K944846 · Organon Teknika Corp. · Jun 1995
LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2
K946048 · Clinical Controls, Inc. · Feb 1995
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · Beckman Instruments, Inc. · Apr 1994
IMMULITE BETA-2-MICROGLOBULIN
K931702 · Diagnostic Products Corp. · Sep 1993