Cleared Traditional

K946069 - HUMAN BETA-2 MICROGLOBULIN ENHANCED NEP...

K946069 is the FDA 510(k) clearance for HUMAN BETA-2 MICROGLOBULIN ENHANCED NEP... by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code JZG) cleared through the Traditional 510(k) pathway after a 433-day FDA review.

K946069 · The Binding Site, Ltd. · Immunology device
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Jan 1996
Decision
433d
Days
Class 2
Risk

K946069 is an FDA 510(k) clearance for the HUMAN BETA-2 MICROGLOBULIN ENHANCED NEPHELOMETRIC KIT. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on January 30, 1996 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all The Binding Site, Ltd. devices

Submission Details

510(k) Number K946069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 1994
Decision Date January 30, 1996
Days to Decision 433 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
329d slower than avg
Panel avg: 104d · This submission: 433d
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 K946069.
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964791 · Bayer Corp. · May 1997
N LATEX B2-MICROGLOBULIN REAGENT
K955596 · Behring Diagnostics, Inc. · Oct 1996
HUMAN BETA-2 MICROGLOBULIN ENHANCED RADIAL IMMUNODIFFUSION KIT
K946068 · 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
IL TEST BETA-2MICROGLOBULIN
K943686 · Instrumentation Laboratory CO · May 1995