Cleared Traditional

K040291 - EL-ANA PROFILES: ANTI-CHROMATIN

K040291 is the FDA 510(k) clearance for EL-ANA PROFILES: ANTI-CHROMATIN by Theratest Laboratories, Inc.. It is a Class 2 Immunology device (product code LJM) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K040291 · Theratest Laboratories, Inc. · Immunology device
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Mar 2004
Decision
34d
Days
Class 2
Risk

K040291 is an FDA 510(k) clearance for the EL-ANA PROFILES: ANTI-CHROMATIN. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on March 11, 2004 after a review of 34 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 Theratest Laboratories, Inc. devices

Submission Details

510(k) Number K040291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2004
Decision Date March 11, 2004
Days to Decision 34 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
70d faster than avg
Panel avg: 104d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
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