Cleared Traditional

BIOPLEX VASCULITIS KIT (K072358) - FDA 510(k) Clearance

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

K072358 · Bio-Rad Laboratories · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 104d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.