Cleared Traditional

K050613 - QUANTIA BETA-2 MICROGLOBULIN

K050613 is an FDA 510(k) clearance for QUANTIA BETA-2 MICROGLOBULIN, manufactured by Biokit, S.A.. The device is a Class 2 Immunology device with product code JZG cleared through the Traditional 510(k) pathway after a 159-day FDA review.

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

FDA 510(k) Submission Details - K050613

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 105d · This submission: 159d
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 46
Devices cleared under the same product code (JZG) and FDA review panel - the closest regulatory comparables to K050613.
DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL M
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K063272 · Dade Behring, Inc. · Jan 2007
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K014270 · The Binding Site, Ltd. · Aug 2002
N LATEX B2-MICROGLOBULIN
K002731 · Dade Behring, Inc. · Nov 2000
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K993711 · Bayer Corp. · Dec 1999