Cleared Traditional

K072358 - BIOPLEX VASCULITIS KIT

K072358 is an FDA 510(k) clearance for BIOPLEX VASCULITIS KIT, manufactured by Bio-Rad Laboratories. The device is a Class 2 Immunology device with product code MVJ cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K072358 · Bio-Rad Laboratories · Immunology device
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Oct 2007
Decision
70d
Days
Class 2
Risk

K072358 is an FDA 510(k) clearance for the BIOPLEX VASCULITIS KIT. Classified as Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (product code MVJ), Class II - Special Controls.

Submitted by Bio-Rad Laboratories (Redmond, US). The FDA issued a Cleared decision on October 31, 2007 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5660 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Rad Laboratories devices

FDA 510(k) Submission Details - K072358

510(k) Number K072358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2007
Decision Date October 31, 2007
Days to Decision 70 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
35d faster than avg
Panel avg: 105d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MVJ Device Classification - Class 2, Special Controls

Product Code MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5660
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 - MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm)

Devices cleared under the same product code (MVJ) and FDA review panel - the closest regulatory comparables to K072358.
ATHENA MULTI-LYTE GBM TEST SYSTEM
K071219 · Zeus Scientific, Inc. · Dec 2007
AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA
K991890 · Cogent Diagnotics , Ltd. · Aug 1999
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
K984619 · The Binding Site, Ltd. · Feb 1999
QUANTA LITE GBM ELISA
K984336 · Inova Diagnostics, Inc. · Feb 1999