Cleared Traditional

K984315 - THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE

K984315 is an FDA 510(k) clearance for THE APTUS (AUTOMATED) APPLICATION OF TH..., manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code MOB cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K984315 · Zeus Scientific, Inc. · Immunology device
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Dec 1998
Decision
14d
Days
Class 2
Risk

K984315 is an FDA 510(k) clearance for the THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LI.... 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 December 17, 1998 after a review of 14 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

FDA 510(k) Submission Details - K984315

510(k) Number K984315 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1998
Decision Date December 17, 1998
Days to Decision 14 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
91d faster than avg
Panel avg: 105d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MOB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MOB Test System, Antineutrophil Cytoplasmic Antibodies (anca)

All 70
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