Cleared Traditional

K001393 - THE APTUS

K001393 is an FDA 510(k) clearance for THE APTUS, manufactured by Zeus Scientific, Inc.. The device is a Class 2 Immunology device with product code MST cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K001393 · Zeus Scientific, Inc. · Immunology device
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Jun 2000
Decision
35d
Days
Class 2
Risk

K001393 is an FDA 510(k) clearance for the THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZ.... Classified as Antibodies, Gliadin (product code MST), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on June 7, 2000 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5750 - 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 - K001393

510(k) Number K001393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2000
Decision Date June 07, 2000
Days to Decision 35 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
69d faster than avg
Panel avg: 104d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MST Device Classification - Class 2, Special Controls

Product Code MST Antibodies, Gliadin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5750
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 - MST Antibodies, Gliadin

All 22
Devices cleared under the same product code (MST) and FDA review panel - the closest regulatory comparables to K001393.
QUANTA LITE GLIADIN IGA II
K052143 · Inova Diagnostics, Inc. · Oct 2005
DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM
K012795 · Diamedix Corp. · Sep 2001
DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM
K012797 · Diamedix Corp. · Sep 2001
AUTOSTAT II ANTI-GLIADIN IGA ELISA
K993086 · Cogent Diagnotics , Ltd. · Nov 1999
AUTOSTAT II ANTI-GLIADIN IGG ELISA
K993087 · Cogent Diagnotics , Ltd. · Nov 1999
THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM.
K993250 · Zeus Scientific, Inc. · Nov 1999