Cleared Abbreviated

K220026 - Genomadix Cube CYP2C19 System (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Abbreviated 510(k) pathway.

K220026 · Genomadix, Inc. · Toxicology device
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Mar 2023
Decision
440d
Days
Class 2
Risk

K220026 is an FDA 510(k) clearance for the Genomadix Cube CYP2C19 System. Classified as Drug Metabolizing Enzyme Genotyping Systems (product code NTI), Class II - Special Controls.

Submitted by Genomadix, Inc. (Kanata (Ottawa), CA). The FDA issued a Cleared decision on March 21, 2023 after a review of 440 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3360 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Genomadix, Inc. devices

Submission Details

510(k) Number K220026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2022
Decision Date March 21, 2023
Days to Decision 440 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
353d slower than avg
Panel avg: 87d · This submission: 440d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code NTI Drug Metabolizing Enzyme Genotyping Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3360
Definition Intended To Identify The Presence Or Absence Of Human Genotypic Markers Encoding Drug Metaboizing Enzymes Using Dna Originating From Clinical Samples. This Type Of Assay Can Be Used As An Aid Determining Treatment Choice And Individualizing Treatment Dose For Therapeutics That Are Metabolized Primarily By The Specific Enzyme Tested By The System.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Toxicology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT04473573 Completed Interventional Industry-sponsored

Spartan Cube CYP2C19 Inter Laboratory Reproducibilty Study

Spartan Cube CYP2C19 Inter Laboratory Reproducibility Study

8
Patients (actual)
3
Sites
Screening
Purpose
Double blind
Masking
Condition studied Genotyping Techniques
Study design Single group
Eligibility All sexes · Healthy volunteers accepted
Principal investigator Shaimaa Ahmed, PhD
Sponsor Spartan Bioscience Inc. (industry)
Started 2019-10-31 → Primary completion 2020-03-17
Primary outcome
% Agreement of test results generated on the Spartan Cube CYP2C19 System and bidirectional sequencing
Study completed - no results published. This trial concluded in 2020 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished. Individual participant data will not be shared.
View full study on ClinicalTrials.gov