Cleared Traditional

K932424 - ANA PROFILE I

K932424 is an FDA 510(k) clearance for ANA PROFILE I, manufactured by Apotex Scientific, Inc.. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K932424 · Apotex Scientific, Inc. · Immunology device
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Aug 1993
Decision
83d
Days
Class 2
Risk

K932424 is an FDA 510(k) clearance for the ANA PROFILE I. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Apotex Scientific, Inc. (Arlington, US). The FDA issued a Cleared decision on August 10, 1993 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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 Apotex Scientific, Inc. devices

FDA 510(k) Submission Details - K932424

510(k) Number K932424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 1993
Decision Date August 10, 1993
Days to Decision 83 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
22d faster than avg
Panel avg: 105d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 80
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K932424.
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K924248 · J.S. Medical Assoc. · Nov 1992