Cleared Traditional

K984516 - THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET (FDA 510(k) Clearance)

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

K984516 · Zeus Scientific, Inc. · Immunology device
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Jan 1999
Decision
24d
Days
Class 2
Risk

K984516 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LIN.... Classified as Test System, Antineutrophil Cytoplasmic Antibodies (anca) (product code MOB), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on January 11, 1999 after a review of 24 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 Zeus Scientific, Inc. devices

Submission Details

510(k) Number K984516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1998
Decision Date January 11, 1999
Days to Decision 24 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
80d faster than avg
Panel avg: 104d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)
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.