Cleared Traditional

CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE) (K930987) - FDA 510(k) Clearance

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

K930987 · The Binding Site, Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 104d · This submission: 166d
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 K930987.
ZEUS IFA(TM) nDNA Test System, ZEUS dIFine
K231616 · Zeus Scientific · Aug 2023
Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System
K203599 · Immuno Concepts, N.A. , Ltd. · May 2023
NOVA Lite DAPI dsDNA Crithidia luciliae Kit
K192916 · Inova Diagnostics, Inc. · Dec 2020
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
ANTI-NATIVE DNA ANTIBODY
K834349 · Sigma Chemical Co. · Apr 1984