Cleared Traditional

K864275 - ANTI-NDNA ANTIBODY TEST KIT

K864275 is the FDA 510(k) clearance for ANTI-NDNA ANTIBODY TEST KIT by Cappel Diagnostics, Inc.. It is a Class 2 Immunology device (product code KTL) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K864275 · Cappel Diagnostics, Inc. · Immunology device
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Dec 1986
Decision
47d
Days
Class 2
Risk

K864275 is an FDA 510(k) clearance for the ANTI-NDNA ANTIBODY TEST KIT. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Cappel Diagnostics, Inc. (Davis, US). The FDA issued a Cleared decision on December 15, 1986 after a review of 47 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 Cappel Diagnostics, Inc. devices

Submission Details

510(k) Number K864275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1986
Decision Date December 15, 1986
Days to Decision 47 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 104d · This submission: 47d
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 9
Devices cleared under the same product code (KTL) and FDA review panel - the closest regulatory comparables to K864275.
EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
K172252 · Euroimmun Us, Inc. · Apr 2018
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM
K013432 · Immuno Concepts, Inc. · Nov 2001
CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
K930987 · The Binding Site, Ltd. · Aug 1993
ANTI-NATIVE DNA ANTIBODY
K834349 · Sigma Chemical Co. · Apr 1984
CODE QAS 103 ANTI-DNA CONTROLS
K791354 · Amersham Corp. · Sep 1979