Cleared Traditional

RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L (K011068) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K011068 · Rhigene, Inc. · Immunology device
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Apr 2002
Decision
367d
Days
Class 2
Risk

K011068 is an FDA 510(k) clearance for the RHIGENE NDNA TEST SYSTEM FOR IMAGETITER, MODEL CL100L. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on April 11, 2002 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Rhigene, Inc. devices

Submission Details

510(k) Number K011068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2001
Decision Date April 11, 2002
Days to Decision 367 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
263d slower than avg
Panel avg: 104d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTL Anti-dna Indirect Immunofluorescent Solid Phase
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 - KTL Anti-dna Indirect Immunofluorescent Solid Phase

All 18
Devices cleared under the same product code (KTL) and FDA review panel - the closest regulatory comparables to K011068.
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ANTI-NATIVE DNA ANTIBODY
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