Cleared Traditional

K083289 - HUMAN BETA-2 MICROGLOBULIN KIT

K083289 is an FDA 510(k) clearance for HUMAN BETA-2 MICROGLOBULIN KIT, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K083289 · The Binding Site, Ltd. · Immunology device
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May 2009
Decision
180d
Days
Class 2
Risk

K083289 is an FDA 510(k) clearance for the HUMAN BETA-2 MICROGLOBULIN 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 May 6, 2009 after a review of 180 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 The Binding Site, Ltd. devices

FDA 510(k) Submission Details - K083289

510(k) Number K083289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2008
Decision Date May 06, 2009
Days to Decision 180 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
75d slower than avg
Panel avg: 105d · This submission: 180d
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 K083289.
HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUS
K122066 · The Binding Site Group , Ltd. · Aug 2012
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
K110874 · Siemens Healthcare Diagnostics, Inc. · Jan 2012
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
K083463 · Siemens Healthcare Diagnostics · Mar 2009
QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307
K072078 · Biokit, S.A. · Dec 2007
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
K063272 · Dade Behring, Inc. · Jan 2007
QUANTIA BETA-2 MICROGLOBULIN
K050613 · Biokit, S.A. · Aug 2005