Cleared Traditional

K030929 - ANA DETECT

K030929 is an FDA 510(k) clearance for ANA DETECT, manufactured by Orgentec Diagnostika GmbH. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K030929 · Orgentec Diagnostika GmbH · Immunology device
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May 2003
Decision
39d
Days
Class 2
Risk

K030929 is an FDA 510(k) clearance for the ANA DETECT. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Orgentec Diagnostika GmbH (Minneapolis, US). The FDA issued a Cleared decision on May 2, 2003 after a review of 39 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.

FDA 510(k) Submission Details - K030929

510(k) Number K030929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2003
Decision Date May 02, 2003
Days to Decision 39 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
66d faster than avg
Panel avg: 105d · This submission: 39d
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 107
Devices cleared under the same product code (LJM) and FDA review panel - the closest regulatory comparables to K030929.
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K022018 · Rhigene, Inc. · Jul 2002
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K030929 · ANA DETECT
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