Cleared Traditional

ANTINUCLEAR ANTIBODY IMMUNOLOGICAL (K833984) - FDA 510(k) Clearance

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

K833984 · Intl. Diagnostic Technology · Immunology device
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Jan 1984
Decision
48d
Days
Class 2
Risk

K833984 is an FDA 510(k) clearance for the ANTINUCLEAR ANTIBODY IMMUNOLOGICAL. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Intl. Diagnostic Technology (Mchenry, US). The FDA issued a Cleared decision on January 4, 1984 after a review of 48 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 Intl. Diagnostic Technology devices

Submission Details

510(k) Number K833984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1983
Decision Date January 04, 1984
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 104d · This submission: 48d
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 K833984.
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EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
K172252 · Euroimmun Us, Inc. · Apr 2018
ANTI-NATIVE DNA ANTIBODY
K834349 · Sigma Chemical Co. · Apr 1984