Cleared Traditional

K834349 - ANTI-NATIVE DNA ANTIBODY

K834349 is an FDA 510(k) clearance for ANTI-NATIVE DNA ANTIBODY, manufactured by Sigma Chemical Co.. The device is a Class 2 Immunology device with product code KTL cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K834349 · Sigma Chemical Co. · Immunology device
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Apr 1984
Decision
128d
Days
Class 2
Risk

K834349 is an FDA 510(k) clearance for the ANTI-NATIVE DNA ANTIBODY. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Sigma Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1984 after a review of 128 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Sigma Chemical Co. devices

FDA 510(k) Submission Details - K834349

510(k) Number K834349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1983
Decision Date April 19, 1984
Days to Decision 128 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 105d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTL Device Classification - Class 2, Special Controls

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 12
Devices cleared under the same product code (KTL) and FDA review panel - the closest regulatory comparables to K834349.
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
K990916 · Stellar Bio Systems, Inc. · Apr 1999
CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)
K930987 · The Binding Site, Ltd. · Aug 1993
DISTAT ANTI-DSDNA KIT
K905386 · Shield Diagnostics, Ltd. · Dec 1990
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
K834140 · Intl. Diagnostic Technology · Jan 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL
K833984 · Intl. Diagnostic Technology · Jan 1984
CODE QAS 103 ANTI-DNA CONTROLS
K791354 · Amersham Corp. · Sep 1979