Cleared Traditional

NOVA Lite DAPI dsDNA Crithidia luciliae Kit (K192916) - FDA 510(k) Clearance

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

K192916 · Inova Diagnostics, Inc. · Immunology device
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Dec 2020
Decision
423d
Days
Class 2
Risk

K192916 is an FDA 510(k) clearance for the NOVA Lite DAPI dsDNA Crithidia luciliae Kit. Classified as Anti-dna Indirect Immunofluorescent Solid Phase (product code KTL), Class II - Special Controls.

Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 11, 2020 after a review of 423 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Inova Diagnostics, Inc. devices

Submission Details

510(k) Number K192916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2019
Decision Date December 11, 2020
Days to Decision 423 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
319d slower than avg
Panel avg: 104d · This submission: 423d
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 K192916.
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K203599 · Immuno Concepts, N.A. , Ltd. · May 2023
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