Cleared Traditional

QUANTIA BETA-2 MICROGLOBULIN (K050613) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050613 · Biokit, S.A. · Immunology device
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Aug 2005
Decision
159d
Days
Class 2
Risk

K050613 is an FDA 510(k) clearance for the QUANTIA BETA-2 MICROGLOBULIN. Classified as System, Test, Beta-2-microglobulin Immunological (product code JZG), Class II - Special Controls.

Submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on August 16, 2005 after a review of 159 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 Biokit, S.A. devices

Submission Details

510(k) Number K050613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2005
Decision Date August 16, 2005
Days to Decision 159 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 104d · This submission: 159d
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 52
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K050613.
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH
K063272 · Dade Behring, Inc. · Jan 2007
N LATEX B2-MICROGLOBULIN
K002731 · Dade Behring, Inc. · Nov 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT
K983895 · Beckman Coulter, Inc. · Nov 1998
TINAQUANT B 2-MICROGLOBULIN ASSAY
K980724 · Boehringer Mannheim Corp. · Oct 1998
IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT
K973813 · Beckman Instruments, Inc. · Nov 1997
IL TEST BETA-2MICROGLOBULIN
K943686 · Instrumentation Laboratory CO · May 1995