Cleared Traditional

K011348 - PHASE II GBM IGG ANTIBODY EIA TEST

K011348 is an FDA 510(k) clearance for PHASE II GBM IGG ANTIBODY EIA TEST, manufactured by Scimedx Corp.. The device is a Class 2 Immunology device with product code MVJ cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K011348 · Scimedx Corp. · Immunology device
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Jun 2001
Decision
54d
Days
Class 2
Risk

K011348 is an FDA 510(k) clearance for the PHASE II GBM IGG ANTIBODY EIA TEST. Classified as Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (product code MVJ), Class II - Special Controls.

Submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on June 25, 2001 after a review of 54 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 Scimedx Corp. devices

FDA 510(k) Submission Details - K011348

510(k) Number K011348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2001
Decision Date June 25, 2001
Days to Decision 54 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 105d · This submission: 54d
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 K011348.
ATHENA MULTI-LYTE GBM TEST SYSTEM
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K072358 · Bio-Rad Laboratories · Oct 2007
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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