Cleared Traditional

K930987 - CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE)

K930987 is an FDA 510(k) clearance for CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOS..., manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with product code KTL cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K930987 · The Binding Site, Ltd. · Immunology device
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Aug 1993
Decision
166d
Days
Class 2
Risk

K930987 is an FDA 510(k) clearance for the CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE). Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on August 10, 1993 after a review of 166 days - an extended review 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: 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 The Binding Site, Ltd. devices

FDA 510(k) Submission Details - K930987

510(k) Number K930987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1993
Decision Date August 10, 1993
Days to Decision 166 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 105d · This submission: 166d
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 K930987.
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
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
K990916 · Stellar Bio Systems, Inc. · Apr 1999
DISTAT ANTI-DSDNA KIT
K905386 · Shield Diagnostics, Ltd. · Dec 1990
ANTI-NATIVE DNA ANTIBODY
K834349 · Sigma Chemical Co. · Apr 1984
ANTINUCLEAR ANTIBODY IMMUNOLOGICAL SYS
K834140 · Intl. Diagnostic Technology · Jan 1984