Cleared Traditional

K071219 - ATHENA MULTI-LYTE GBM TEST SYSTEM

K071219 is an FDA 510(k) clearance for ATHENA MULTI-LYTE GBM TEST SYSTEM, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code MVJ cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K071219 · Zeus Scientific, Inc. · Immunology device
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Dec 2007
Decision
218d
Days
Class 2
Risk

K071219 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE GBM TEST SYSTEM. Classified as Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (product code MVJ), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 6, 2007 after a review of 218 days - an extended review 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: 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 Zeus Scientific, Inc. devices

FDA 510(k) Submission Details - K071219

510(k) Number K071219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2007
Decision Date December 06, 2007
Days to Decision 218 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d slower than avg
Panel avg: 104d · This submission: 218d
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 K071219.
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