Cleared Traditional

K990916 - INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY

K990916 is an FDA 510(k) clearance for INDIRECT FLUORESCENCE ASSAY FOR ANTI-NA..., manufactured by Stellar Bio Systems, Inc.. The device is a Class 2 Immunology device with product code KTL cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K990916 · Stellar Bio Systems, Inc. · Immunology device
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Apr 1999
Decision
34d
Days
Class 2
Risk

K990916 is an FDA 510(k) clearance for the INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on April 21, 1999 after a review of 34 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 Stellar Bio Systems, Inc. devices

FDA 510(k) Submission Details - K990916

510(k) Number K990916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1999
Decision Date April 21, 1999
Days to Decision 34 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 105d · This submission: 34d
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 K990916.
EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
K172244 · Euroimmun Us, Inc. · Apr 2018
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
DISTAT ANTI-DSDNA KIT
K905386 · Shield Diagnostics, Ltd. · Dec 1990
ANTI-NATIVE DNA ANTIBODY
K834349 · Sigma Chemical Co. · Apr 1984