Cleared Traditional

K203599 - Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System (FDA 510(k) Clearance)

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

K203599 · Immuno Concepts, N.A. , Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2023
Decision
898d
Days
Class 2
Risk

K203599 is an FDA 510(k) clearance for the Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent.... Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Immuno Concepts, N.A. , Ltd. (Sacramento, US). The FDA issued a Cleared decision on May 26, 2023 after a review of 898 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Immuno Concepts, N.A. , Ltd. devices

Submission Details

510(k) Number K203599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2020
Decision Date May 26, 2023
Days to Decision 898 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
794d slower than avg
Panel avg: 104d · This submission: 898d
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.