Cleared Traditional

K943686 - IL TEST BETA-2MICROGLOBULIN

K943686 is the FDA 510(k) clearance for IL TEST BETA-2MICROGLOBULIN by Instrumentation Laboratory CO. It is a Class 2 Immunology device (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

Submission Details

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
186d slower than avg
Panel avg: 104d · This submission: 290d
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 37
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
BECKMAN BETA-2-MICROGLOBULIN (B2M)
K940353 · Beckman Instruments, Inc. · Apr 1994
IMMULITE BETA-2-MICROGLOBULIN
K931702 · Diagnostic Products Corp. · Sep 1993
DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)
K915508 · Diagnostic Systems Laboratories, Inc. · Mar 1992